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Information for Industry

Revised:  6 October 2017

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
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
427 Murphys Road
Flat Bush
Manukau city
Auckland 2016
Phone : 0064 9 2714839
Mobile : 0064 221537249
E-mail : avanjit1@gmail.com
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
Nancy Yopp
Managing Director
6 Church Lane
Point Howard
Lower Hutt 5013
Phone: +64 4 569 6060
Mobile: +64 27 270 9594
Email: nancy@brandwoodbiomedical.com
Web: www.brandwoodbiomedical.com

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
Brandwood Biomedical Pty Ltd
Arthur Brandwood, Managing Director
Suite 408, 460 Pacific Highway
St Leonards NSW 2065
Australia
Phone Office: +61 (0)2 9906 2984
Fax: +61 (0)2 8580 4613
E-mail: enquiries@brandwoodbiomedical.com.au
Web: www.brandwoodbiomedical.com.au
Medical devices
Applications for new/changed medicines
Applications for new/changed related products
Applications for rescheduling of medicines
Clinical trials
Good Manufacturing Practice
Pharmacovigilance
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
50B Puketapu Road, Taradale, Napier 4112
PO Box 766, Hastings
Brian Day
Phone: (06) 844 4490
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
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
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 3913 & (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
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
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
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
PCR Ltd New Zealand
24 Portsea Place, Chatswood, North Shore, Auckland 0626
Dr Felix S F Ram
Phone: (+64) 021-1077729
E-mail: fsfram@yahoo.co.uk
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

Pharma To Market Pty Ltd
Nick Ward
Co-Director
Level 1, 7 Clunies-Ross Court
Brisbane Technology Park
Eight Mile Plains QLD 4113
Australia
Phone: +61 (0)7 3122 9979
Mobile: +61 (0)406 606 036
E-mail: nick.ward@pharmatomarket.com
Web: www.pharmatomarket.com

Applications for new/changed medicines
Applications for new/changed related products
Good Manufacturing Practice
Medical Writing
Electronic Submissions
Training

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
Quality and Regulatory Services Limited [QRSL]
15 Ambassador Glade, Orewa, Auckland 0931
Martyn Gillam
Mobile: +64 (0)21 654 966
E-mail: qrslimited@gmail.com
Good Manufacturing Practice
Applications for new/changed medicines
Applications for new/changed related products
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
Rob Allman Consulting
14 Spencer Street, Crofton Downs, Wellington
Rob Allman
Phone: (04) 4791029
Mobile 021 1024268
E-mail: rl.allman@xtra.co.nz
Applications for new/changed medicines
Applications for new/changed related products
Medical devices
Good Manufacturing Practice
Rob Jelas
477 Stokes Valley Road
Lower Hutt 5019
Phone - 021 844 020
Email - devices@jelas.org.nz
Website - www.jelas.org.nz
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
P. O. Box 51-598, Pakuranga, Auckland
Gillian Alexander
Phone: (09) 533 7171
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
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
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
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
Web: www.anza.co.nz

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
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