Revised: 12 May 2025
Information for Industry
Regulatory Consultants
Medsafe has been informed that the following people provide independent regulatory, clinical and other consultancy services to the therapeutic products sector in New Zealand (as of November 2012). These people work independently of Medsafe. Medsafe accepts no liability for the qualifications, accuracy or reliability of these consultants. No warranty or recommendation is to be assumed from the provision of this information or the omission of contact details for any other consultant.
| Company | Services |
|---|---|
|
360 Pharma Consulting Services Pty Ltd |
Applications for new/changed medicines (Prescription and OTC) Applications for new/changed related products (Prescription and OTC) Medical devices Regulatory strategies Project management Applications for transfer/rescheduling of medicines Good Manufacturing Practice |
|
Accelagen Pty Ltd Offices in Australia and New Zealand Phone: +61 3 9114 2270 Email: info@accelagen.com.au Web: www.accelagen.com.au |
Applications for new/changed medicines (Prescription and OTC) Applications for new/changed related products (Prescription and OTC) Medical devices Regulatory and commercialisation strategies Market access – Reimbursement strategies Competitor analysis & market insights Pharmacovigilance Risk management Clinical development Clinical trials Good Manufacturing Practice Auditing Recalls Advertising |
|
Adjutor Healthcare Group Offices in Australia and New Zealand Joseph Badolato PhD - Senior Business Development Manager Phone: +61 (0)410467573 Email: contact@adjutor.com.au Web: https://www.adjutor.com.au |
Advertising Applications for new/changed prescription medicines Applications for transfer/rescheduling of medicines Auditing Clinical trials Commercialisation strategies Competitor analysis & market insights Device vigilance and reporting Due diligence Gap analysis Good Laboratory Practice (GLP) Good Manufacturing Practice (GMP) In vitro diagnostics (IVDs) ISO 13485 Market access & reimbursement Medical affairs Medical devices Medical information Medical writing Pharmacovigilance & adverse event reporting Prescription medicines Project management Quality Management Systems - development & audits Recalls Regulatory submissions - local and international Regulatory submissions - medicines and devices Risk management Small to large companies, tailored services for startups Sponsorship - medicines and devices Strategy - concept to commercialisation Strategy - local and international Technical & scientific writing Training |
|
ADVANTAGE Medical products Consulting Pty Ltd Unit 204/1013 Gold Coast Highway Palm Beach QLD 4221 AUSTRALIA Brenley M MILSOM Phone: +61 7 55224880 Mobile +61 (0) 407533048 E-mail: bmilsom@advantagempc.com.au Web: www.advantagempc.com.au |
Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice Pharmacovigilance Advertising |
| All Biomedical Engineering and Regulatory Specialist
Services Ruth Grant Phone: 04 5278793 Mobile: 021313169 E-mail: regrantnz@yahoo.com |
Advertising Applications for new/changed related products Clinical trials Good Manufacturing Practice Medical devices |
| APPharma Consulting Pty Ltd PO Box 2046, Normanhurst, NSW 2076, AUSTRALIA Jeff Song Phone: +61 401 091 878 Email: jeff.song@appharma.com.au Web: www.appharma.com.au |
Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Good Manufacturing Practice Advertising |
| AnQual GLP Laboratories School of Pharmacy, The University of Auckland A/Prof. Sanjay Garg Phone: (09) 373 7599 ext 82836 E-mail: s.garg@auckland.ac.nz Web: http://www.fmhs.auckland.ac.nz/sop/anqual/ |
Applications for new/changed medicines Applications for new/changed related products Medical devices Clinical Trials Good Manufacturing Practice |
| Archer Emery & Associates PO Box 7136, Yarralumla, ACT 2600, Australia Paul Archer, Julie Emery Phone: +61 2 6281 3873 E-mail: parcher@archeremery.com.au Web: www.archeremery.com.au |
Applications for new/changed medicines Applications for new/changed related products Medical devices Clinical Trials Good Manufacturing Practice Pharmacovigilance Advertising |
|
Avani Goswami Consulting |
Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice Pharmaceutical Software Services |
| BELTAS™ Ltd PO Box 99 728, Newmarket 1149 AUCKLAND Gerard Dunne Phone: (09) 520 2410 E-mail: contact.health@beltas.com Web: www.beltas.com |
Medical devices Clinical Trials Pharmacovigilance |
|
BioEquitas Ltd Samantha Gray Phone: 021 1197226 E-mail: samantha@bioequitas.co.nz Web: www.bioequitas.co.nz |
Dietary Supplements Food/Dietary Supplement Interface Supplemented Foods Regulations Foods Regulations and Health Claims Self-Substantiated Health Claims Dossiers Hemp & CBD Advertising inc Digital and Social Media Label Compliance & Copy Product Development – concept to commercialisation Global Market Regulatory Strategies - including: TGA Australia Complementary Medicines US FDA 21 CFR 111 Dietary Supplements Competitor Analysis & Market Insights Levels of Evidence Strategy R&D project management and cofunding Project Management & Trials Technical Troubleshooting - in process & analytical Technical & Scientific Writing Commercialisation Strategies Good Manufacturing Practice Auditing and Gap Analysis Good Laboratory Practice Analytical Methods and Validation Technical Due Dilligence Small to Large Companies - tailored services for startups |
| Biotech Regulatory Solutions Katy King Principal Consultant PO Box 51 Church Point NSW AUSTRALIA Phone: + 61 2 9999 4770 E-mail: katy@biotechregulatory.com.au Web: www.biotechregulatory.com.au |
Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Clinical trials Good Manufacturing Practice Device vigilance/reporting Due diligence on dossiers or life cycle of products Gap analysis Medical affairs Medical information Medical writing Pharmacovigilance Prescription medicines Project management Quality Management Systems Recalls Risk management Sponsorship Strategy Dossier writing and publication (eCTD and NeeS) Training |
| Biotec Solutions Limited 35 Roscommon Road, Manukau, Auckland, Dr. Sachin Samant Phone: (09) 2789496 E-mail: Sachin@biotecsolutions.co.nz Web: www.biotecsolutions.co.nz |
Good Manufacturing Practice |
| BioValeo Ltd Clinical Trial CRO & Consultants Julie Jones Phone: +64 22 355 3088 Email: contact@biovaleo.com Web: www.biovaleo.com |
Auditing Clinical Trials Clinical Trial Regulatory & Ethics Applications / Activities Clinical Trial Consultant Clinical Trial Contract Research Organisation (CRO) Feasibility Assessment ICH Good Clinical Practice (GCP) ISO 14155 Local Sponsor Medical Technology / Devices Pharmaceutical Products Project Management, Monitoring, Data Management Risk & Quality Management Site & Investigator identification Training Research & Development Support Vendor Selection & Management |
| Brigid Glass & Associates Ltd Brigid Glass, Consultant and Coach 43 Campbell Rd, Maraetai, Auckland 2018 PO Box 281030, Maraetai Beach, Auckland 2148 Phone: +64 9 535 3119 E-mail: brigid.glass@brigidglassassociates.net Web: http://nz.linkedin.com/in/brigidglass |
Medical Devices |
| Caduceus Medical Development, Ltd Tara M. Creaven-Capasso, MAppSc., RQAP-GLP, RAC Founding Partner / Managing Director 16 Ihaka Street Palmerston North 4410 Phone: +64 (0) 21 623005 Email: tcreaven@caduceus-consulting.com |
Medicinal Cannabis Medical Devices Pharmaceutical Medicines Device and Medicines Sponsorship Good Manufacturing Practice ISO 13485 ISO 17025 Quality Management Systems Auditing Applications for new/changed medicines Applications for transfer/rescheduling of medicines Regulatory strategy development Commercialisation strategies Advertising |
| Cameron Healthcare Ltd Helen Teale, Managing Director 8/137 Jervois Road, Herne Bay, Auckland 1011 PO Box 46096, Herne Bay, Auckland 1147 Phone: +64 9 360 8528 Mobile: +64 21 738 205 E-mail: helen@cameronhealthcare.co.nz Web: www.cameronhealthcare.co.nz |
Clinical Trials Medical Devices Applications for new/changed medications Pharmacovigilance Advertising Medical Writing |
| Caroline Norwood Consulting 15 Empire Road, Devonport, Auckland 0624, NZ Caroline Norwood Mobile: +64 21 378 445 Email: c.norwood@outlook.com |
Applications for new/changed medicines Medical devices |
| CARSL Consulting PO Box 766, Hastings 4156 New Zealand Brian Day & David Smyth Phone: 027 488 4411 & 027 508 6002 E-mail: brian@carsl.co.nz, david@carsl.co.nz & carsl@xtra.co.nz Web: www.carsl.co.nz |
Sponsorship of Medicines & Medical Devices Medical Devices Device Vigilance & Reporting Recalls & FSN’s Clinical Trials Pharmacovigilance Applications for new/changed Medicines Applications for new/changed related products Dietary Supplement Compliance Advertising Quality Management Systems |
| Cassandra Hogan Fontein Professional Services Email: cassandra@fonteinccs.co.nz |
Medical Writing |
| Category 1 Pharma Consulting Pty Ltd Kingsville Victoria Australia Phone: + 61 412 800 845 Email: info@category1pharma.com Web: www.category1pharma.com |
Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Good Manufacturing Practice |
|
Chill Division Limited Josiah Spackman Phone: +6499735087 Email: josiah+consult@chilldivision.co.nz Web: www.chilldivision.co.nz |
Advertising - Compliance Medicinal Cannabis Technical writing (SOPs) Training |
| Commercial Eyes Pty Ltd Level 11, 500 Collins Street Melbourne VIC 3000, AUSTRALIA Phone: +61 3 9251 0777 E-mail: : info@commercialeyes.com.au Web: http://commercialeyes.com.au/ |
Applications for new/changed medicines (Prescription and OTC) Applications for new/changed related products (Prescription and OTC) Medical devices Regulatory and commercialisation strategies Market access – Reimbursement strategies Market insight Pharmacovigilance & risk management Medical Information Medical Affairs Advertising Clinical development Dietary supplements Good Manufacturing Practice |
| Rosalind Dalefield PhD DABT DABVT Phone: 027 543 6668 E-mail: rosalind@dalefield.com Web: http://www.toxi.co.nz |
Applications for new/changed medicines Preclinical trials Preclinical Good Laboratory Practice |
| e-MAS Medicine Advertising Service Emi Gosling (principal consultant & pharmacist) Sydney, Australia Phone: +61 (0)2 9484 3336 Mobile: +61 (0) 43 838 2505 Email: Emi@e-MAS.com.au Web: www.e-MAS.com.au |
Advertising – Compliance (Consumer) Advertising – Advisory (OTC, Complementary Meds, devices) Digital and Social Media advertising Medicine Interface – Foods and Cosmetic D-T-C Medical Writing Training |
| Engel, Hellyer &Partners Pty Limited Level 4, 815 Pacific Highway, Chatswood, NSW 1515, Australia PO Box 5462, West Chatswood NSW 1515, Australia Dr Graeme Haley, Sandie Rooke, Ray Maio Phone: +61 2 9413 9799 E-mail: enquiries@engelhellyer.com Web: www.engelhellyer.com |
Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice Advertising |
| Enimera RegsPlus |
Applications for new/changed medicines Applications for new/changed related products Prescription medicines, OTC, dietary supplements Medicinal cannabis Applications for rescheduling of medicines Good Manufacturing Practice Advertising Medical writing Clinical trials Non/pre-clinical trials Pharmacovigilance Compliance/gap assessments |
| ERA Consulting Level 3, 88 Jephson Street, Toowong, QLD 4066, Australia Mr Tristan Elliott Phone: +61 (7) 3331 3900 E-mail: info@eraconsulting.com Web: www.eraconsulting.com |
Applications for new/changed medicines Clinical trials |
|
Gallandeer Ridge Pty Ltd |
Applications for new/changed
medicines Applications for new/changed related
products |
| Erin Gentry B.Pharm(Hons), MPS, RegPharmNZ ThirtyThree, PO Box 74166, Greenlane, Auckland 1546 Email: erin@thirtythree.co.nz Web: www.nz.linkedin.com/in/eringentry3 |
Advertising Medical Writing and Medical Information Pharmacovigilance |
| Global Compliance (International) Ltd 7 Grant Avenue, Russell, Bay of Islands Ashley Hankinson Phone: +64 9 4037897 Mobile: +64 210 77898 and +44 7788720621 E-mail: Ashley@nordiccomplianceservices.com Web: www.nordiccomplianceservices.com |
Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice |
| GMP Consultancy Services Limited 73- Fruitvale Road, New Lynn. Auckland Mateen Siddiqui Phone: (09) 8264474, mob 021 252 1855 E-mail: Mateen.siddiqui@yahoo.co.nz |
Good Manufacturing Practice |
|
Grayson Wagner Consulting Limited |
Technical & Scientific Writing
|
| Green Lane Coordinating Centre Level 1, 2163 Great North Road, Avondale, Auckland, New Zealand Olga Bucan Phone: (09) 820 2050 E-mail: contact@glcc.org.nz Web: www.glcc.org.nz |
Clinical Trials |
|
H.Temple Consulting Wellington, New Zealand Mobile: +64 21 2989092 E-mail: hannah@htempleconsulting.com Web: htempleconsulting.com |
Applications for new/changed medicines Applications for new/changed related products Medical devices Advertising |
| Health Audit NZ Limited PO Box 38610,Howick, Manukau 2145 Mike Thornber Phone: 0274 977833 E-mail: haudit@ihug.co.nz |
Clinical Trials Good Manufacturing Practice |
|
HPB Consulting Limited Pierre Booysen Mobile: 022 0565 456 Email: pierre.booysen@hpbconsulting.co.nz Web: www.hpbconsulting.co.nz |
Good Manufacturing Practices Audits Training Medicinal Cannabis - Licenses and Products |
| InsightReg Consultancy Elvina Hsi Phone: +64 204 358462 Email: elvina.hsi@insightregulatory.co.nz |
Regulatory compliance and strategy from concept, product development to commercialisation covering the following classifications:
Services including compliance checks for:
Global regulatory launch strategy covering overseas markets such as Australia, USA, UK, China, Hong Kong, Singapore and Malaysia etc. Fluent in both English and Mandarin. |
| International Certifications Limited 30 Bishopsgate Business Centre, Bishop Dunn Pl, Botany South, Auckland Dave Evans Phone: (09) 273 4099 or 0800 ISO 9001 E-mail: admin@intlcert.com Web: www.intlcert.com |
Medical devices Good Manufacturing Practice |
|
Johner Institute Anne Arndt Director Engineering Building, Level 1 2 Worcester Boulevard Christchurch 8013 Phone: +64 (0) 20 41831943 E-mail: Annett.Arndt@Johner-Institut.co.nz |
Active Medical Devices Software as Medical Device Expert witness for Software as Medical Device (No. 1-22-1016) Regulatory strategy development (FDA, EU, TGA) Quality Management System according to ISO 13485 and FDA 21 CFR 820 Technical Dossier / Design Controls / Design Dossier according to requirements TGA, EU, FDA and according to
Surveillance activities required by the authorities or standards
|
| KD & A Pty Limited Phone: 0411 101 392 Email: kdent@kdas.com.au Web: www.kdas.com.au |
Medical devices |
| Keene Manufacturing Solutions 59 John Gill Rd, Howick, Auckland Richard Keene Phone: (09) 534 5347, 021 278 1845 E-mail: keeneman@xtra.co.nz |
Good Manufacturing Practice System and Supplier Auditing Dietary Supplements Quality System Development Recalls GMP Training |
| Keith Holmes Consulting 50 Sartors Avenue, Browns Bay, Auckland 0630 Dr Keith Holmes Phone: (09) 476-8082 Mobile: 027 276 8082 E-mail: keith.holmes@ihug.co.nz |
Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Clinical trials Good Manufacturing Practice Pharmacovigilance Advertising |
| Kim Walker Consulting Kim Walker, MS, RAC (US & EU) Global RA & QA Consultant Skype Contact: kwconsulting Email: kwconsulting@socal.rr.com or kim@kimwalkerconsulting.com Web: www.kimwalkerconsulting.com |
Advertising Applications for New/Changed Medical Products Clinical Trials Dietary Supplements Good Laboratory Practice Good Manufacturing Practice & Quality System Development/Audits Labelling Medical Devices & IVDs Medical Writing Pharmacovigilance & Adverse Event Reporting Prescription & OTC Medicines Recalls Training |
|
KSJ Pharmatech 9/7 Anella Ave, Castle Hill NSW 2154 Mr Jai Kanuru Phone: +61-401 858 985 |
Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice Advertising Dietary supplements |
|
MAAB International Limited Beini Su (based in Nelson) Email: betty.su@maab-group.com Mobile: +64 27 526 3131 Web: www.maab-group.com |
China Regulatory strategy consultancy and registration
services Pharmaceutical registration in China Medical device registration in China IVD registration in China |
| Medconsult Limited 46 Braemar Road, Rothesay Bay, Auckland 0630 PO Box 35-927, Browns Bay, Auckland 0753 Maureen Roberts Phone: (09) 478 7776 Mobile: 021 68 77 60 Fax: 09 478 7731 E-mail: maureenroberts@xtra.co.nz |
Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice Pharmacovigilance Advertising |
| MediNova Ltd 7 Grant Avenue, Russell, Bay of Islands Ashley Hankinson Phone: +64 9 4037897 Mobile: +64 210 778987 E-mail: Ashley@mdnova.com Web: www.nordiccomplianceservices.com |
Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Clinical trials Good Manufacturing Practice Pharmacovigilance |
| MSR Consultancy Ltd Richard Mayfield Phone: +64 (0)9 427 9987 Fax +64 (0)9 427 9987 Mobile 021 628 379 E-mail: richard.mayfield@xtra.co.nz |
Preclinical trials Preclinical Good Laboratory Practice |
| MTA Pharma Consulting PO BOX 1210 Glen Waverley Victoria 3150 Australia Contact: Mark Mariathas email:kmariath@tpg.com.au mobile: + 61 413325697 |
Applications for new/changed medicines Good Manufacturing Practice Advertising |
| Neon Consulting Chris Mander 40B Howe Street, Howick, Auckland 2014 Phone: 021 0249 4240 Email: neon@xtra.co.nz |
Medical devices |
| New Wayz Consulting Ltd P.O. Box 36-496, Northcote 0748 Auckland Maurice Parlane Phone: (09) 419 8029 E-mail: info@newwayz.co.nz Web: http://www.newwayz.co.nz |
Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice |
| Nordic Compliance Services Ltd PO Box 119 Russell Bay of Islands 0242 Phone: +64210778987 E-mail: ashley@nordiccomplianceservices.com Web: www.nordiccomplianceservices.com |
Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice Pharmacovigilance |
|
Pharma To Market Pty Ltd |
Applications for new/changed medicines |
| Pharmaceutical Solutions Limited Level 1, The Levy Building, 20 Customs Street East Britomart Business Precinct Auckland 1010 Linda Hill Phone: +64 9 379 8205 Fax +64 9 379 8244 Web: www.pharmasols.com |
Advertising Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Clinical trials Good Manufacturing Practice Medical devices Medical writing Pharmacovigilance |
| PharmAffairs Regulatory Services Limited 29 James Evans Drive, Northcote, Auckland 0627 Pauline Harris Phone: (09) 419 9451 Mobile: 021 185 0566 |
Applications for new/changed medicines Applications for new/changed related products |
|
PharmaLex Pty Ltd Level 10, 1 Chandos Street, St Leonards NSW 2085 Australia Phone: +61 2 9906 2984 Mobile: +61 467 629 317 Email: enquiries.au@pharmalex.com Web: www.pharmalex.com |
Applications for new/changed medicines (OTC and Prescription)
Applications for new/changed related medicines Electronic Submissions Applications for reclassification of medicines Clinical Trials Good Manufacturing Practice Research and Development Support Regulatory and commercialisation Strategies Pharmacovigilance Medical Information Materials Compliance Review Patient Programs |
| Philippa Davies and Partners Consulting
Philippa Davies BPharm, RegPharmNZ, MPS, PG DipBusAdmin Mobile: +64 21 1756590 Email: philippadavies27@outlook.com Web: https://www.linkedin.com/in/philippa-davies-16830336/ |
Regulatory strategic advice Market access strategic advice Advertising (prescription, OTC, dietary supplements) Compliance with industry and advertising codes of practice Medicines Classification Committee submissions Medical Affairs Business planning Business cases (BBC trained) Project Management |
|
Practical Quality and Regulatory Ltd Offices in UK and New Zealand Stephen Smith PhD, CQP FCQI, FTOPRA, Co-Founder Maria Vella MD MRCOG, Co-Founder Tel: NZ: +64 (0) 21 08105789 UK: +44 (0) 7835169490 E-mail: stephen@practicalqara.com Web: https://www.practicalqara.com |
Medical Device/IVD
|
|
Produco Ltd Colin Oliver Phone: +64 21 2453650 E-mail: info@produco.co.nz |
Medicinal Cannabis regulations Hemp & CBD TGA Australia Complementary Medicines Labelling Compliance Technical due diligence Market Access Quality Management Systems Good Manufacturing Practice |
| Quality Associates a Division of Tranzsoft Group Ltd PO Box 303-190, North Harbour AUCKLAND, Phone: (09) 448 2075 Fax (09) 448 1371 Mobile (Steve) (027) 561 2292 E-mail: steve@qai.co.nz Web: www.qai.co.nz |
Good Manufacturing Practice |
|
Qudos Shirlene Moore Phone: +64 (0) 204 122 6365 E-mail: shirlene.moore@qudos.co.nz Website: https://www.qudos.co.nz |
Good Manufacturing Practice GxP (Good Laboratory Practice, Good Wholesaling Practice etc.) Auditing Recalls Gap Analysis Quality System Setup Dietary Supplements, Medicines GxP Training Technical writing (Technical Reports, SOPs) |
|
R-Line Limited trading as Foodaction Phill Dromgool Phone: 027 575 3348 Freephone: 0800 475 463 Email: phill@foodaction.co.nz Web: www.foodaction.co.nz |
Food/Dietary Supplement Interface Dietary Supplement Formulation Dietary Supplement Labelling Supplemented Food Labelling Supplemented Food Formulation Health and Nutrition Claims TAPS Submissions Exporting of dietary supplements Self Substantiated Health Claims Novel Foods |
|
Reg IQ Pty Ltd Carnegie VIC 3163 Australia Natasha Tepic Director Phone: +61 409 183 594 Email:natasha@regiq.com.au Web: www.regiq.com.au |
Medicines:
Food & beverages:
Regulatory & commercialisation strategies Gap analysis Dossier writing Technical report writing Recalls |
| Regulatory Concepts Pty Ltd 9/7 Anella Ave, Castle Hill, NSW 2154, Australia Dr. Helena Dickenson Phone: +61 (0) 2 9846 1900 E-mail: helenad@regcon.com.au, info@regcon.com.au Web: www.regcon.com.au |
Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice Advertising |
| Regulatory Par Excellence Laurence Garceau Director and Principal Consultant 3/76 Merlin Street, Neutral Bay NSW 2086 Australia Phone: + 61 415 706 915 E-mail: laurence.garceau@regexcel.com Website: www.regexcel.com |
Applications for new/changed medicines Applications for new/changed related products Medical devices Clinical trials |
| Research Associates Limited P.O.Box 17-539, Christchurch, Tony Mann Phone: 021 713671 E-mail: tony@ral-nz.com Web: www.ral-nz.com |
Clinical Trials |
| Revio Pharmaceutical Consultants, S.L.U. Phone: +34 656 659 636 Email: regaffairs@reviopharma.com Website: www.reviopharma.com |
Regulatory strategy and submissions Regulatory Strategy and Roadmaps. Regulatory Preparation & Submissions: CTA, IND, IMPD, IB, MAA, NDA/BLA, DMF, ASMF, etc. Regulatory Agency Interaction: Scientific Advice (EMA and national), FDA meetings, ITF meetings, EMA/HTA parallel consultation, PRIME, BTD, RMAT, Orphan Drug Designation, PIP/PSP. Regulatory Lifecycle Management. Other regulatory activities: ATMP classification and certification, SME status. Due diligence Inlicence. Outlicence. CMC, Non-clinical and Clinical Strategic development. Revision/writing CMC, NC and C documents. Review clinical protocols, FIH, Exploratory and Confirmatory. Agency meeting preparation and attendance. Draft/review CMC, nonclinical and clinical data, defend and review company position. CMC Technical Advisory Manufacturing and Quality. Analytical Method Development/Validation. Potency Assay strategy. Release and Stability testing, Specifications. Process Development and Validation, QbD.Identification of CMO, Technology Transfer and Comparability |
| Right Time Business Pty Limited PO Box 55 Glen Iris Victoria 3146 Melbourne Australia Roy Hardman Phone: +61 3 98855388, +61 419 100 978 E-mail: roy@righttimebusiness.com.au Web: www.righttimebusiness.com.au |
Medical devices |
| Robert Forbes and Associates Level 1, 335-341 Glebe, Point Rd (cnr Ferry Rd), Glebe (Sydney) NSW 2037 Australia Robert Forbes Phone: +61 2 96608027 E-mail: RFAinfo@robert-forbes.com Web: www.robert-forbes.com |
Applications for new/changed medicines Applications for new/changed related products Good Manufacturing Practice Advertising |
|
Scendea (AUS) Pty Limited Phone: +61 721 398 527 Email: info@scendea.com Web: https://www.scendea.com/ |
Drug Development Planning Regulatory Strategy Development US Specific Regulatory Activities EU Specific Regulatory Activities AUS Specific Regulatory Activities Paediatric Development Agency Interactions Orphan Drug Designation CMC/Quality Development Aspects Non-clinical/Toxicology Development Aspects Clinical Development Aspects Resolving Product Development Issues Marketing Approval/Preparation And Revisions Technical/Medical/Regulatory Writing Clinical Trial Associated Regulatory Activities Programme/Project Management Vendor Selection & Management |
|
Scientific & Regulatory Solutions Sydney, Australia Contact: Jim Moshovelis Mobile: +61 406 948 498 Email: info@sciregsolutions.com.au Web: www.sciregsolutions.com.au |
Applications for new/changed medicines Applications for new/changed related products Good Manufacturing Practice Quality Management / Systems Audits Regulatory & Commercialisation Strategies Dietary Supplements Food & Beverages Training |
| Spectrum Technology Pty Limited P.O. Box 422 Glenhuntly Victoria 3163 Australia Harry Pose Phone: +613 9578 1420 E-mail: h.pose@bigpond.com Web: www.harrypose.com |
Applications for new/changed related products Medical devices Good Manufacturing Practice |
| Statistecol Consultants Limited 51 Woodside Rd, Mt Eden Auckland Chris Frampton Phone: 0272729378 E-mail: statistecol@xtra.co.nz |
Applications for new/changed medicines Clinical trials |
| The SPD Company Pty Ltd Renée Simon Business Manager NZ and Australia Mobile: +61 402 546 792 E-mail: enquiries@theSPDcompany.com.au |
Pharmaceuticals, Medical Devices and Biotechnology. New Zealand,
Australia, Europe, US.
|
| Therapeutic Advertising pre-Vetting System (TAPS) Adjudicator 96 Hazelwood Ave, Karori, Wellington 6012 Peter Pratt Phone: (04) 938 6409 E-mail: peterpratt@paradise.net.nz Web: www.anza.co.nz |
Advertising |
| Therapeutic Advertising pre-Vetting System (TAPS) Adjudicator Nicola Pearce Mobile: 021 645575 Email: nicolapearcetaps@xtra.co.nz Web: www.anza.co.nz |
Advertising |
| Therapeutic Advertising Pre-Vetting System (TAPS) Co.
Association of New Zealand Advertisers Inc. 46 Braemar Road, Rothesay Bay, Auckland 0630 |
Advertising |
|
Value-Based Access Pty Ltd ABN: 42 237 591 962; ACN: 161 694 195 PO Box 310 Thornleigh, NSW 2120 Australia Eugene Salole PhD MPH Mobile: +61-409 041 976 E-mail: esalole@valuebasedaccess.com Web: www.valuebasedaccess.com LinkedIn: https://au.linkedin.com/in/eugene-salole-ab8ab732 |
Medical devices and diagnostics: Health technology assessment (HTA) Market access strategies Value communication; Global Value Dossiers Value-based 3rd-party funding propositions ‘Selling with evidence’: Sales and Marketing staff training in communicating product value Local research studies to demonstrate product value Stakeholder engagement |
| Weir Regulatory Consulting 83 Tania Ave, Palmwoods, QLD 4555, Australia Jo Weir Director and Principal Consultant Phone: +61 428 144 267 E-mail: jo.weir@weirconsulting.com.au Website: www.weirconsulting.com.au |
Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Good Manufacturing Practice Advertising Medical writing |
| Yasmeen & Associates Apartment G03, 112 Waterdale Road, Ivanhoe, Victoria 3079, Australia Dr Dilruba Yasmeen Phone: +61 3 9848 4770 or +61 (0)409 144 036 E-mail: dyasmeen@bigpond.net.au |
Applications for new/changed medicines Applications for new/changed related products Gap analysis Dossier writing Technical Report Writing |
