Revised: 1 May 2019
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 |
| ADVANTAGE Medical products Consulting Pty Ltd 5 Yatama Place, Currumbin Waters, QLD 4223, AUSTRALIA Brenley MILSOM Phone: +61 7 55224880 Fax +61 7 55224128 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 |
| Biotech Regulatory Solutions Katy King Principal Consultant PO Box 135 Church Point NSW AUSTRALIA Phone: + 61 2 9979 2180 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 |
| 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 |
|
Brandwood Biomedical NZ Ltd |
Medical Devices 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 Commercialisation strategies Advertising |
| 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 |
Applications for new/changed medicines Applications for new/changed related products Medical devices Clinical Trials Good Manufacturing Practice Pharmacovigilance 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 |
| Capital K Consulting Pty Ltd Suite 5, 4-10 Hillcrest Road, Pennant Hills 2120 NSW, Australia Phone: +61 (0)2 8407 9585 Fax: +61 (0)2 9475 1252 Mobile: +61 (0)411 021 377 Email: enquiries@capitalk.com.au Web: www.capitalk.com.au |
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 |
| Caroline Norwood Consulting 15 Empire Road, Devonport, Auckland, 0624 Caroline Norwood Mobile: +64 21 378 445 Email: cnga@xtra.co.nz |
Applications for new/changed medicines Applications for new/changed related products Medical devices Good Manufacturing Practice Pharmacovigilance Advertising |
| CARSL Consulting 24 Side Road, Parkhill Farm, RD10, Hastings PO Box 766, Hastings Brian Day Phone: (06) 875 0979 E-mail: carsl@xtra.co.nz Web: www.carsl.co.nz |
Applications for new/changed medicines Applications for new/changed related products Medical devices Clinical Trials Good Manufacturing Practice Pharmacovigilance Advertising |
| Cassandra Hogan Fontein Consulting Solutions Papamoa, Tauranga Phone: 021 324 103 Email: fontein.consulting.solutions@gmail.com Web: https://www.linkedin.com/in/cassandra-hogan-7975a556/ |
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 |
| 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 |
| 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 |
| Ethos Consulting Group 33 Old Hautere Road, Te Horo, RD2, OTAKI 5582 Mike Thompson Phone: (06) 364 3912 & (021) 364 391 Email: mike.ethos@gmail.com |
Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Clinical Trials Advertising |
| 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 |
| 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 |
| Hannah Temple Consulting 7 Makomako Road, Brooklyn, Wellington 6021 Hannah Temple Mobile: 021 298 9092 E-mail: hannah.temple2@gmail.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 |
| In Vivo Communications Building E, 27-29 William Pickering Drive. Albany, North Shore City PO Box 300 667, Albany, North Shore City, 0752 Lisa Sullivan Phone: (09) 448-5408 E-mail: l.sullivan@invivocom.com Web: www.invivocom.com |
Applications for new/changed medicines Applications for new/changed related products Clinical Trials Advertising Medical Writing |
| INC Research NZ Ltd. (formerly Trident Clinical
Research NZ Ltd.) PO Box 305191, Triton Plaza, North Shore 0757, Auckland Michael Gibson Phone: +64 (0)9 555 8101 Fax: +64 (0)9 478 0560 E-mail: mgibson@incresearch.com Web: www.tridentclinicalresearch.com and www.incresearch.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 |
| 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 |
| KD & A Pty Limited Level 1, 251 Hutt Street, Adelaide, South Australia Kea Dent Phone: 0011 64 823 28358 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 |
| Maria Laitenberger Consulting New Plymouth, Taranaki, New Zealand Maria Laitenberger, B. Eng, M.A.Sc., RAC Phone: +64 021 166 0289 E-mail: maria.laitenberger@gmail.com Web: www.linkedin.com/in/mlaitenberger |
Medical devices Quality Management Systems (ISO 13485, FDA 21 CFR 820) Good Manufacturing Practice (GMP) compliance Risk Management (ISO 14971) and Usability Engineering (IEC 62366) Labeling and Unique Device Identification (UDI) Regulatory pathway assessment for international market entry Regulatory submissions to international markets (e.g., Australia, USA, Europe, Canada) Regulatory gap analysis (e.g., transition from EU MDD 93/42/EEC to EU MDR) Technical support (e.g., biocompatibility testing, sterilization validation, packaging validation, aging testing, performance testing) Small to large companies, tailored services for startups |
| 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 |
| Medra & Pharma Services Limited 563 Makino Road RD 9, Feilding 4779 Graham Leslie Phone: +64 6 3238573 Mobile: +64 274 537543 E-mail: medra@xtra.co.nz |
Applications for new/changed medicines Applications for new/changed related products Advertising Good Manufacturing Practice Medical devices Pharmacovigilance |
| Michelle Carbines Regulatory Consultant PO Box 224, Matakana 0948. Michelle Carbines Phone: (09) 423 8855 E-mail: mcarbines@slingshot.co.nz |
Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Clinical Trials 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 |
| Pharmamark NZ Ltd 162 Nile Road Auckland John Wickens Phone: +64 9 4109077 Mobile +64 21 1173 473 E-mail: john@pharmamark.co.nz |
Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Advertising |
| 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 |
| 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 |
| 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 |
| 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 |
| Saltarelo Limited 22 Coney Hill Road, St. Clair, Dunedin Gillian Alexander Phone: 021 868 200 E-mail: Saltarelo@xtra.co.nz |
Applications for new/changed medicines Applications for new/changed related products Applications for rescheduling of medicines Medical devices Pharmacovigilance Advertising |
|
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 43 Tirohunga Drive, Henderson, Auckland Nigel Andrews Phone: (09) 836 2680 E-mail: nigel@rubicon.net.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 |
| 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 4 Chapel Court, Doncaster, Victoria 3108, Australia Dr Dilruba Yasmeen Phone: +61 3 9848 4770 E-mail: dyasmeen@bigpond.net.au |
Applications for new/changed medicines Applications for new/changed related products |
