Consultants PDF

2014 List of Consultants (see Disclaimer)
Company Name / Address

ACERNA Inc.
19 Bryant Road
Markham, ON
L3P 5Y7
Contact Information
Paul J. Larocque, President
Tel: 905-472-5747
Summary of Services (see Notes)

Product Areas:
Pharmaceuticals
Biologics
Medical Devices
Over-the-counter Products
paul.larocque@acerna.ca
www.Acerna.ca
Adiantum Consultant-e
Boucherville
Qubec
Amei-Can Regulatory
Experts
7256 Airport Road
Suite 111
Mississauga, Ontario
L4T 3V1
Julie Naud
Tel: 450-641-2696
Fax: 450-655-0204
j.naud@adiantumconsultant-e.com
www.adiantumconsultant-e.com
ameri-can@live.com
www.americanregexperts.com
Food
Cosmetics
OTC pharmaceuticals
Natural Health Products
Dietary supplements
Pharmaceuticals
Medical Devices Natural
Health Products
Services:
Good Manufacturing Practices,
especially for sterile, aseptic, and
biological processes
Compliance resolution, including
Health Canada and FDA Warning
Letters
Medical Device Quality Systems
Regulatory Affairs
Adiantum consultant-e: for your
scientific and regulatory needs
NPN, OTC DIN, Site licensing,
SOPs, Supplement Facts table,
Nutritional Facts table, Site
licensing, label text revision, etc.
Ameri-Can Regulatory Experts
helps importers/manufacturers/
distributors for Product
Registrations
Establishment/Site Licensing,
Liaison with Health Canada
SOP Development
GMP Compliance, release/reject
programs and facilitate Health
Canada audits and registered
trademark.
REGULATORY AFFAIRS MADE
EASY
Countries:
Canada
United States
Europe
Canada
United States
Canada,
United States
Australia

Contact Information
AmoSey Inc.
Suite 11
39-173 Advance Boulevard
Brampton, ON
L6T 4Z7
Canada
Sharavathi Ponnuswamy
AxSource Consulting Inc.

336 Bronte Street South
Suite 224-225
Milton, ON
L9T 7W6
Ms. Navneet Sekhon, President
Tel: 647-624-9628
Fax:289-597-1631
shara@amoseyinc.com
www.amoseyinc.com
Tel: 905-854-6059
Cell: 416-452-0100
nav.sekhon@axsource.ca
www.axsource.ca

Product Areas:
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Drugs/Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Services:
A to Z of Pharmaceutical Industry
Regulatory Submissions,
Compliance, GXP, pre-approval
Inspections,
QA, Validation, Clinical Research,
Pharmacovigilance, Formulary
Advertising
eCTD service
Translation Services for > 30
languages
GMP,GLP,GCP & ISO
Regulatory Affairs, QA/QC,
Compliance, Clinical, Engineering,
Validations incl. Software (CSV)
Pre-inspection, Compliance &
consultant audits
On-site & Virtual RAQA services
EH&S services
Clinical Laboratory Consulting &
Certification services
Litigation support
Countries:
Canada
United States
Europe
Asia
India
Australia
Canada
United States
Europe
Asia
Australia

BNA Consultant Group
301, Dorval Av.
Suite 120
Dorval, Quebec
H9S 2H6
Contact Information
Rachid Akhiate
Tel: 514-774-1046
Fax: 514-631-3868
r.akhiate@gbnac.com
www.GBNAC.com
Canadexlabs
725 Place Fortier #707
Montreal, Quebec
H4L 5B9
Mr. Fayez Chehab

Tel: 514-978-4466
Fax: 514-747-7550
fayez@canadexlabs.com
www.canadexlabs.com
Certus PV Services
11-1155 North Service Road
West
Oakville, ON L6M 3E3
Canada
Rita Cassola
Tel: 289-291-3942
contact@certuspv.com
www.certuspv.com

Product Areas:
Cosmetics
Veterinary Drugs
Medical Devices
Food
Pharmaceuticals
Veterinary Drugs
Medical Devices
Cosmetics
Pharmaceuticals
Biologics
Radiopharmaceuticals
Cosmetics
Veterinary Drugs
Services:
Regulation of natural health
products
Health supplements
Foods and pharmaceuticals
Assists natural health product and
pharmaceutical companies to
facilitate and guide them through
the regulation procedures
Health Canada drug submissions:
(NDS) (SNDS)
(ANDS) (NC) (DIN)
Health Canada Natural Health
products submissions: (NPN)
Quality Control & Quality
assurance
GMP Compliance & Product
registration
Certus PV provides expert preapproval and post-market
pharmacovigilance as well as
medical information services
Countries:
Canada
Canada
United States
Europe
Gulf Arabic
States (GCC
countries)
Canada
United States

Chestnut Solutions Inc.
86 Otter Cres.
Toronto, ON
M5N 2W8
Contact Information
Helen Teichman

Product Areas:
Pharmaceuticals
Tel: 416-783-2945
hteichman@rogers.com
www.chestnutsolutions.com
Coley Consulting Inc.

991 Peggoty Circle
Oshawa, Ontario
L1K 2G5
Consultations Madgo
6-1297,rue Jasmin
Laval, Quebec
H7W 3V9
Consultations Nathalie
Lebel Inc.
1768 chemin St-Charles,
Local 101
Terrebonne, Quebec
J6W 0B7
Alan Coley
416-786-4916
905-436-2808
alan.coley@rogers.com
www.alancoleyconsulting.com
Madeleine Gomez
Tel: 450-416-0922
Fax: 450-416-4922
nathalie.lebel@lebelpharma.com
www.lebelpharma.com
eCTD and NeeS publishing and

management.
Implementation and best practices
for electronic submissions and
document management
Templates, training, SOP
preparation
Countries:
Canada
United States
Europe
Pharmaceuticals Biologics
Veterinary Drugs
Medical Devices
Regulatory Submissions
Quality Systems Development and
Implementation
Good Manufacturing Practices
GAP Analysis Training
Canada
United States
Europe
Pharmaceuticals
Medical Devices
Quality Management and

Assurance
Regulatory Affairs
For additional information visit our
website
Canada
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Regulatory Affairs
Quality Control and Quality
Licensing
Client representation during Health
Canada Inspection and negotiation
with Health Canada
Training and Education
Canada
Tel: 450-973-9553
info@consultationsmadgo.com
www.consultationsmadgo.com
Nathalie Lebel
Services:

dicentra
27 Prince Arthur Avenue
Toronto, ON
M5R 1B2
DSA Consultants
1660 North Service Road E.
Units 106 & 107
Oakville, ON, L6H 7G3
Canada
Contact Information
Peter Wojewnik
Tel: 416-361-3400
Fax: 416-361-3304
peter@dicentra.com
www.dicentra.com
Mark Moody
Tel: 905-827-0057 ext.229
Fax: 905-827-0060
info@dsaconsultants.com
www.dsaconsultants.com
Eric Leblanc
36 Bellefeuille
Mercier
Qubec, J6R 2P2
Canada
Eric Leblanc

Product Areas:
Pharmaceuticals
Medical Devices
Cosmetics
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
MMPR
Pharmaceutiques
Biologiques
Tel:514-929-4891
E-mail: leblanceri@gmail.com
Services:
dicentra provides sought-after
regulatory and scientific guidance
on health-related products sold in
North American marketplaces.
Countries:
Canada
United States
Regulatory Affairs, Quality Control

and Quality Assurance
Product Registrations,
Liaison with Health Canada, SOP
Development, GMP Compliance,
Audits and more
Pharmacovigilance
Canada
Canada
United States
CMC regulatory affairs compliance

IND and CTA in eCTD format
Technical writing
Technology transfer
Analytical procedure development
and validation
Quality assurance
GMP compliance audit

FasTrack Consulting
12 Forestgrove Drive
Ottawa, ON K2S 1V2
Contact Information
Dr. Kathy A. Zito
Tel: 613-286-2089
kathyzito@fastrackconsulting.com
www.fastrackconsulting.com
Grieb Consulting
(VG Solutions)
1060 de Canna
Laval, QC
H7X 3W4
Victoria Grieb
Tel: 450-314-3545, 514-651-0465
Fax: 450-314-3585
vgrieb@vgsolutions.ca

Product Areas:
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Medical Marijuana
Plant-based
Pharmaceuticals
Pharmaceuticals
Medical Devices
Cosmetics
Food
Services:
Countries:
Canada
United States
Europe
Regulatory affairs for cosmetics,

OTC drugs, NHPs and food
DIN, NPN applications, Medical
device licenses
Liaison Health Canada
Regulatory training
GMP, QA/QC
Packaging review
Environmental compliances
Certificates of Free Sale (ITCs)
English or French, including
translations
Canada

Innovia-Biopharma
141 rue Ovila
Rosemere, Quebec
J7A 4L2
Contact Information
Gilles Chaumillon
Tel: 514-918-5677
Fax: 450-965-0105

Product Areas:
Pharmaceuticals
Veterinary Drugs
Medical Devices
Cosmetics
www.innovia-biopharma.com
contact@innovia-biopharma.com
International Food Focus
Ltd.
211 Carlton Street
Toronto, ON
M5A 2K9
Carol T. Culhane
Tel: 416-924-3266
Fax: 416-924-2726
cculhane@foodfocus.on.ca
www.foodfocus.on.ca
Intertek Scientific &

Regulatory Consultancy
2233 Argentia Rd.,
Suite 308
Mississauga, ON
L5N 2X7
Anna Metcalfe
Tel: 905-542-2900
Fax: 905-542-1011
heather.cormack@intertek.com
Food Ingredients
Novel Foods
Novel Fibres
Processed Food
Infant Formula
Animal Feed Supplements
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Services:
Regulatory Submissions (drug,
NPN, device),
Regulatory/Quality Compliance
Quality system implementation
(ISO 13485, HACCP)
Internal & External Audits
Pre-commercialization and premarket notification: assimilation of
scientific dossiers for regulator
review
Post-commercialization label
creation (including French
translation) or audit
Regulatory and market impact
studies
Learning & Development
seminars and workshops
Intertek's experts provide
assistance at all stages of product
development to clients in the
pharmaceutical, biotechnology,
and medical device fields
Countries:
Canada
Canada
USA
EU
Canada
United States
Europe
Asia
Africa
Australia
Latin America

Contact Information
Intrinsik Health Sciences

Inc.
6605 Hurontario Street
Suite 500
Mississauga, Ontario
L5T 0A3
Katharine Manson
JC QA Consultants Inc.
10 Parkview Place
Brampton, ON L6W 2G1
Canada
John Collins
Tel: 905-450-5798
Cell: 647-985-8764
Tel: 905-364-7800 ext. 209

Fax: 905-364-7816

Product Areas:
Pharmaceuticals Biologics
Veterinary Drugs Medical
Devices Cosmetics
kmanson@intrinsik.com
www.intrinsik.com
johnco@sympatico.ca
www.jcconsultants.ca
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Non-prescription drugs
Medical Marijuana
Services:
Intrinsik Health Sciences is a
specialized group of regulatory and
toxicology professionals with
backgrounds from large and
emerging pharmaceutical,
biotechnology companies, and
consulting firms. Cumulatively, our
team provides your company with
years of relevant experience to
help with all stages of drug
development
Quality & Compliance Experts for
Pharmaceutical, Natural Health
and Medical Marijuana Products.
Expertise in Audits/Inspections
(Performing/Hosting), APRs/QPRs,
Batch Release/Certification,
Computer Validation, Clinical QA,
Deviation & CAPA Management,
Medical Marijuana, QA
Agreements, Risk Assessments
(Site/Vendor/Product),Site Quality
Management, Stability
Review/Protocols, Temperature
Monitoring/Cold Chain Packaging,
Training, Validation
Countries:
Canada
United States
Europe
Asia
Australia
Canada
United States
Europe

K. Friedman Consulting
537 Bedford Park Ave.
Toronto, ON
M5M 1K4
Contact Information
Karen Friedman

Product Areas:
Pharmaceuticals
Tel: 416-783-9394
Fax: 416-783-3114
karenfriedman@rogers.com
www.kfriedmanconsulting.com
Lockhart Regulatory
Services Inc.
1860 Appleby Line,
Suite 348
Burlington, Ontario
L7L 7H7
Marilyn Lockhart
Tel: 905 635-2855
mplockhart@sympatico.ca
Pharmaceuticals
Medical Devices
Over-the-Counter
Products
Services:
Preparation of natural health
product applications and site
license applications
Preparation of new and
supplemental new drug
submissions, clinical trial
applications, notifiable changes
Preparation of DIN applications
Cosmetic regulatory affairs
QA
Drug Establishment Licenses
MMPR Consulting for Licensed
Producers
Experienced
Results-Oriented
Recognized
Regulatory and Quality
Countries:
Canada
Canada
United States

MarcM Consulting Canada
172 Mausser Avenue
Kitchener, ON
N2M 3K7
McCarthy Consultant
Services, Inc.
1151 Gorham Street
Unit 8
Newmarket, ON
L3Y 8Y1
Contact Information
Marcela Saad
Tel: 519-579-0821
Fax: 519-579-0821
marcmconsulting@marcmconsulting
.ca
www.marcmconsulting.ca
http://ca.linkedin.com/pub/marcelasaad/7/30b/bb3
Dorothy Partridge
Tel: 905-836-0033
Fax: 905-836-0006
dpartridge@mccarthyconsultant.com
www.mccarthyconsultant.com
MCS Associates Inc.
1060 Tapscott Road
Toronto, Ontario
M1X 1E7

Product Areas:
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Foods
Tel: 416-286-6062 Ext. 227

Fax: 416-286-0146
shelleys@reena-enterprises.com
www.mcs-associates.com
10
Services:
Regulatory strategy, product
registrations & post-market
changes
Clinical trial & establishment
license applications
Quality System & GMP/GCP/ISO
compliance
Extensive expertise in the
Americas in English, Portuguese &
Spanish
MCSI is trusted and valued by the
pharmaceutical, biotechnology,
medical device, food, natural
health products and cosmetic
industries for its efficient, timely,
and effective regulatory work.
Countries:
Canada
United States
Latin America
Europe
Canada
United States
Europe

Natural Products Consulting
Corporation
29 East Wilmont Street
Richmond Hill, Ontario
L4B 1A3
Contact Information
Lionel Pasen

Product Areas:
Tel: 905-763-9999
Fax:905-784-1110
lionel@npc-corp.ca
www.npc-corp.ca
Normand Robichaud
Services conseils inc.
4025 chemin Sainte-Foy
Quebec, Quebec
G1Y 1T7
Normand Robichaud
Nutrasource Diagnostics
Inc.
Suite 203
120 Research Lane
University of Guelph
Research Park,
Guleph, ON
N1G 0B4
Krista Coventry, M.Sc.
Tel: 418-650-5628
normand.robichaud@videotron.ca
www.normandrobichaud.com
Tel: 519-341-3363
Fax: 519-341-3368
kcoventry@nutrasource.ca
www.nutrasource.ca
Pharmaceuticals
Medical Devices
Cosmetics
Pharmaceuticals
Functional Food &
Beverages
Foods
Medical Devices
Cosmetics
11
Services:
Since 1959:
NHPs,OTCs,cosmetics,dietary
supplements,foods,Site
Licences,claim substantiation.
Notarized International Trade
Certificates. Computerized
applications (over 6000
completed), efficient and cost
effective
Services conseils en Bonnes
Pratiques de Fabrication (BPF)
Systmes Qualit
Audits Qualit
Conformit pour lindustrie
pharmaceutique, cosmtique, des
biotechnologies et des produits de
sant naturels
Regulatory Affairs Project
Management
Regulatory Applications
(Pharmaceuticals/NHPs/ Medical
Devices/Foods)
Clinical Trial Design/
Implementation/
Monitoring/Data Management
Facility Compliance
(Auditing/GMPs/SOPs)
Countries:
Canada
United States
Latin America
Canada
United States
Europe
Canada
United States

Optum
(formerly CanReg Inc.)
4 Innovation Drive
Dundas, ON
L9H 7P3
Contact Information
Darrell Ethell
Tel: 905-689-3980
Fax: 905-689-1465
Darrell.ethell@optum.com
www.optuminsight.com/srs
Pharmalink Consulting
51 John F Kennedy Pkwy,
4th Fl
Short Hills, NJ
07078
USA
Ghali Asad
Tel: 973-921-5247
gasad@pharmalinkconsulting.com
www.pharmalinkconsulting.com

Product Areas:
Pharmaceuticals
Biologics
Medical Devices
Cosmetics
Pharmaceuticals
Biologics
Medical Devices
Cosmetics
12
Services:
Regulatory Affairs, CMC and QA
services
eCTD & NeeS (preparation,
management and hosting)
Pharmacovigilance/Medical
Information
CTAs/Canadian agent services
Canadian Importer of Record
Quality systems (GMP, ISO13485)
Environmental regulatory
Whatever your needs, FDA
regulations or working with global
regulatory affairs agencies we can
resource any healthcare regulatory
affairs project, regardless of size
and timescale.
Our expertise has been developed
and crafted by working for many
years in the continually evolving
healthcare arena.
Countries:
Canada
United States
Europe
Asia
Africa
Australia
Latin America
Canada
United States
Europe
Asia
Africa
Australia
Latin America

Contact Information
PharmEng Technology
23 Lesmill Road,
Suite 410
Toronto, ON M3B 3P6
Canada
Ben Lee
Proficio Scientific Affairs Inc.

3700 St-Patrick
Suite 240
Montreal, Quebec
H4E 1A2
Simon Alexander
Tel: 416-385-3922 ext. 103

Fax: 416-385-3912
info@pharmeng.com
www.pharmeng.com
www.medmarijuanaexperts.com
Tel: 514-296-0125
Fax: 514-933-7208
info@proficioconsult.com
www.proficioconsult.com

Product Areas:
Pharmaceuticals
Biologics
Devices Cosmetics
MMPR
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
13
Services:
Commissioning & Qualification
Validation
Regulatory Affairs
Quality Control
Engineering
Project Management
Serialization
Tech Transfer
Information Technology
SOPS
Audits
MMPR Consulting
Training
Expert Regulatory Support for:
Clinical Trials (devices, drugs,
biologics)
Product Registration; eCTD
Health Authority Meetings &
Negotiations
Post-market & Life-cycle
management
20 years regulatory affairs &
development experience
Countries:
Canada
United States
Europe
Asia
Africa
Australia
Latin America
Canada

PRTox Consulting Inc.
922 Pezer Cres
Saskatoon
Saskatchewan, S7S 1J8
Contact Information
Daniel Bechtel
Tel: 306-652-6271
info@prtox.ca
prtox.ca
Quality & Compliance

Services Inc.
9-6975 Meadowvale Town
Centre, Suite 410
Mississauga, ON
L5N 2V7
Stephen Semple
Tel: 905-363-1182, ext.210
Fax: 905-542-7981
ssemple@qualityandcompliance.com
www.qualityandcompliance.com
RaQa Consulting Inc.
4 Robert Speck Parkway
15th Floor
Mississauga, ON
L4Z 1S1
Sandra Ireland
Tel/Fax: 1-866-697-7272
info@raqaconsulting.ca
www.raqaconsulting.ca

Product Areas:
Services:
Countries:
Pharmaceuticals
Veterinary Drugs
Cosmetics
Pest Control Products
Consumer Chemicals and
Containers
Regulatory guidance, dossier

preparation and submission.
Toxicology protocol development
and management.
Scientific guidance for analytical,
environmental and human health
regulatory documentation.
Canada
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
Cosmetics
Q &C s full-time consultants

provide complete regulatory,
quality control and compliance
services for the pharmaceutical,
natural health product, cosmetic
and medical device industries and
their suppliers.
Canada
United States
Europe
Asia
Australia
Latin America
Medical Devices
Cosmetics
Drugs
Foods
Complete Business Solutions and

Project Management for
manufacturing/importing and
distributing drugs, medical devices,
cosmetics and NHP's.
Canada
United States
14

Redstone Health Group Inc.
2125 Galena Cres.
Oakville, ON L6H 4A9
Canada
Contact Information
Karen Feltmate

Product Areas:
Pharmaceuticals
Tel: 905-842-4230
Fax: 905-338-8970
Services:
We provide strategic and
operational regulatory support that
align and enhance your greater
business strategy.
Countries:
Canada
kfeltmate@redstonehealthgroup.co
m
www.redstonehealthgroup.com
Reg-Affairs & QualiPractixis
Inc.
370 Stone Road, Suite 20
Guelph, ON N1G 4V9
Canada
Olufemi Adeoye
Tel: 226-780-0216
Fax: 226-780-0216
Pharmaceuticals
Devices Cosmetics
femi.adeoye@reg-affairsqp.com
www.reg-affairsqp.com
15
We provide Regulatory and Quality

compliance services that cover the
entire life-cycle of the following
healthcare products:
- Prescription & OTC Drug
Products
- Medical Devices
- Natural Health Products (only
in Canada)
- Cosmetic Products
- Low Risk Veterinary Health
Products (LRVHP)
Canada
United States
Europe
Asia
Africa
Australia
Latin America

Regxia Inc.
5-133 The West Mall
Toronto, ON
M9C 1C2
Contact Information
Cameron McGregor
Tel: 416-620-5236
Fax: 416-620-0261

Product Areas:
Pharmaceuticals
Biologics
Veterinary Drugs
Medical Devices
mcgregor@regxia.com
www.regxia.com
Regulatory Solutions Inc.

5 Strawberry Hill Court
Caledon, ON
L7E 1R9
Jane P. Costaris
Tel: 905-857-3132
Fax: 905-857-3816
Pharmaceuticals
Medical Devices
jane.costaris@sympatico.ca
www.regulatorysolutions.ca
16
Services:
Regulatory Affairs
Dossier Compilation &
Management
eCTD (preparation, management
and publishing)
CMC
Clinical & Quality services
Clinical Monitoring & Management
Pharmacovigilance
SOPs & Reporting
CTAs, IND, NDS, ANDS, etc.
RSI specializes in timely,
innovative and strategic Regulatory
Affairs approvals from Health
Canada ((S)ANDS, (S)NDS,
DIN(A), DEL, Post-NOC)
Provincial Formulary Submissions
eCTD Submissions
Pharmacovigilance
Countries:
Canada
United States
Europe
Canada

Robin Loconte
150 Forbes Terrace
Milton, ON
L9T 4V1
Contact Information
Robin Loconte

Product Areas:
Pharmaceuticals
Biologics
Tel: 905-805-1349
Robin.locente@gmail.com
Source Nutraceutical, Inc.

1 1249 Clarence Avenue
Winnipeg, Manitoba
R3T 1T4
Bernie Desgagnes
Tel: 204-254-2234
Fax: 204-254-7817
berniedesgagnes@sourcenutra.ca
www.sourcenutra.ca
Pharmaceuticals
Veterinary Drugs
Medical Devices
Cosmetics
17
Services:
Specializing in the development
and execution of regulatory
strategies to support Canadian
product approvals:
Canadian Health Authority
submissions
Regulatory risk assessment
Regulatory strategy development
Health Authority meetings
Expert Advisory Boards
Document writing
Presentation development
Your one-stop-solution for
regulatory compliance, graphic
design, bilingual labeling and
importation and fulfillment services
for foods, natural health products,
cosmetics, medical devices and
pharmaceutical products
Countries:
Canada
Canada
United States

SPEK Regulatory
Consultants
4080 Farnsworth Cres.
Mississauga, ON
L5L 3Z3
Contact Information
Sunita Phull / Ella Dratewka-Kos

Product Areas:
Pharmaceuticals
Tel: 647-234-4930
416-560-6637
Fax: 416-223-9875
spek.consulting@gmail.com
SpringBoard Solutions Inc.

1332 Nocturne Court
Mississauga, ON
L5H 2L8
Sheila Garven
Pharmaceuticals
Biologics
Tel: 416-619-9025
sheila@springboardsolutions.ca
www.springboardsolutions.ca
18
Services:
40+ years of combined experience
- Regulatory advice and strategy
- Post-marketing changes
- DIN submissions
- NHP submissions (PLAs)
- Establishment Licence
submissions
- CTAs and Amendments
- Pre-CTA meetings and GCP
inspection support
- SOP development for
regulatory processes.
Regulatory support in the filing and
approval of drug submissions
Development of position papers on
regulatory policy issues
Provide affidavits and testimony in
patent cases
Countries:
Canada
Canada

Stan North Consultation
166 Promenade Sheraton
Montreal-Ouest
Quebec, H4X 1N4
Contact Information
Stan North, M.Sc.
Tel: 514-577-5913
info@StanNorthConsultation.com
www.StanNorthConsultation.com
SYLLA CONSEILS INC.

2149 Lincourt
Longueuil, Quebec
J4N 1N8
Sylvie Lachance
Tel: 450-332-0928
Cell:514-823-0928
Fax:450-332-0928

Product Areas:
Pharmaceuticals
Biologics
Medical Devices
Cosmetics
Pharmaceuticals
Veterinary Drugs
Medical Devices
Cosmetics
sylvie-lachance@videotron.ca
www.syllaconseils.com
Therapeutic Products Inc.

1269 Centre Rd.
Hamilton, ON
L8N 2Z7
Anne Tomalin
Tel: 905-690-4343
Fax: 905-690-4242
Pharmaceuticals
Biologics
atomalin@tpireg.com
19
Services:
Regulatory consulting for the
pharma, medical device and
biotech sectors
Clinical and CMC submissions
CTAs
Project management
Product monographs and labeling
Regulatory guidance and strategy
We offer quality service, flexibility
and customer-focus with over 20
years of industry experience
Regulatory Affairs
DIN,NPN applications & Medical
device licences
Establishment/Site Licensing
QC/QA implementation & follow-up
GMPs, GLPs,SOPs training
Internal & External Audits
Liaison with Health Canada & FDA
during inspection
Packaging review
Regulatory consulting
Pharmacovigilance services
Countries:
Canada
Canada
United States
Europe
Canada
United States

Trillium Technologies Group
Inc.
7271 Warden Avenue
Suite 42/43
Markham, ON
L3R 5X5
Contact Information
Ravi Joshi
Tel: 1-905-604-8604
Fax: 1-905-604-8605
info@trilliumconsult.com
www.trilliumconsult.com

Product Areas:
Pharmaceuticals
Biopharmaceuticals
Medical Devices
OTC Products
Cosmetics
Services:
Product Development
Regulatory Affairs
Qualification & Validation
Clinical Operations
Quality Assurance
Compliance Audits
Countries:
Canada
United States
Europe
Asia
List of Consultants
The list comprises consulting companies whose primary focus is Regulatory Affairs, Clinical Research, Quality Control or Compliance (GCP, GLP, GMP) for
pharmaceuticals, biologics, veterinary drugs, medical devices, cosmetics, over-the-counter products, or natural health products. Companies are listed
alphabetically by company name.
List of Acronyms:
DIN = Drug Identification Number
DMF = Drug Master File
GCP = Good Clinical Practice
GLP = Good Laboratory Practice
GMP = Good Manufacturing Practices
NHP = Natural Health Product
QA = Quality Assurance
QC = Quality Control
RA = Regulatory Affairs
SOP = Standard Operating Procedures
20
Notes:
Clinical Trials Research includes conduct of trials (Phases I-IV), bioanalytical, data management and statistical services.
GCP includes guidance on requirements, preparation of SOPs, conduct of audits and GCP training.
GLP includes guidance on requirements, preparation of SOPs, conduct of audits and GLP training.
GMP includes guidance on requirements, preparation of SOPs, conduct of audits and GMP training.
Product Development includes guidance on requirements for moving through the therapeutic product development process.
Quality Assurance/Quality Control (QA/QC) includes arranging appropriate product testing and release.
Regulatory Affairs (RA) comprises review, assessment and preparation of appropriate regulatory documentation. Expertise in Clinical and/or Quality
(chemistry and manufacturing) aspects is specified.
Toxicology includes nonclinical drug development and safety programs.
Disclaimer:
CAPRA / ACPR maintains this List of Consultants as a service to industry and to the regulatory authorities. The individual companies have provided the
information on the list for presentation in a standard format. CAPRA / ACPR does not endorse any of the consultants on the list.
21

Consultants PDF

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Consultants PDF

Uploaded by

Copyright:

Available Formats

2014 List of Consultants (see Disclaimer)

Company Name / Address

Summary of Services (see Notes)

2014 List of Consultants (see Disclaimer)

AxSource Consulting Inc.

Ms. Navneet Sekhon, President

Summary of Services (see Notes)

2014 List of Consultants (see Disclaimer)

Mr. Fayez Chehab

Summary of Services (see Notes)

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

Coley Consulting Inc.

eCTD and NeeS publishing and

Quality Management and

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

Regulatory Affairs, Quality Control

CMC regulatory affairs compliance

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

Regulatory affairs for cosmetics,

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

Intertek Scientific &

2014 List of Consultants (see Disclaimer)

Intrinsik Health Sciences

Tel: 905-364-7800 ext. 209

Summary of Services (see Notes)

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

Tel: 416-286-6062 Ext. 227

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

Krista Coventry, M.Sc.

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

2014 List of Consultants (see Disclaimer)

Proficio Scientific Affairs Inc.

Tel: 416-385-3922 ext. 103

Summary of Services (see Notes)

2014 List of Consultants (see Disclaimer)

Quality & Compliance

Summary of Services (see Notes)

Regulatory guidance, dossier

Q &C s full-time consultants

Complete Business Solutions and

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

We provide Regulatory and Quality

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

Regulatory Solutions Inc.

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

Source Nutraceutical, Inc.

2014 List of Consultants (see Disclaimer)

Summary of Services (see Notes)

SpringBoard Solutions Inc.

2014 List of Consultants (see Disclaimer)