Consultants - Copy

8/11/2019 Consultants - Copy

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2013 List of Consultants (see Disclaimer)

Company Name / Address Contact InformationSummary of Services (see Notes)

Product Areas: Services: Countries:

ACERNA Inc.

19 Bryant Road

Markham, ON

L3P 5Y7

Paul Larocque

Tel: 905-472-5747

[email protected]

www.Acerna.ca

Pharmaceuticals

Biologics

Medical Devices

Over-the-counterProducts

Good Manufacturing Practices

Quality Systems

Regulatory Affairs

Compliance

Training

Canada

United States

Europe

AmoSey Inc.

#719, 8-Maison Parc CourtThornhill, ON

L4J 9K5

Sharavathi Ponnuswamy

Tel: 647-624-9628Fax:289-597-1631

[email protected]

www.AmoSey.com

Pharmaceuticals

BiologicsVeterinary Drugs

Medical Devices

Cosmetics


Natural Health Products

A to Z of Pharmaceutical

Industry like:Establishment/Site Licensing,

Regulatory Submissions,Regulatory/Quality Compliance,GXP, pre-approval Inspections,QA, Validation, Clinical Trials,Pharmacovigilance, Patents and

Advertising

eCTD services

Canada

United StatesEurope

Asia

India

Australia

Authentication LegalizationServices Canada

400-1390 Prince of WalesOttawa, ON

K2C 3N6

Bill Strange

Tel: 613-226-1001

1-800-336-1132Fax:613-226-7402

1-866-217-7402

[email protected]

www.ALSCanada.ca

Pharmaceuticals

Biologics

Veterinary DrugsMedical Devices

Cosmetics



20+ years experience assistingcompanies from the

Pharmaceutical, Medical DeviceManufacturing, Cosmetic and

Animal Health Industries withDFAIT certificate authenticationand embassy legalizationservices.

Canada

United States

EuropeAsia

Africa

Australia

Latin America
mailto:[email protected]:[email protected]://www.acerna.ca/http://www.acerna.ca/mailto:[email protected]:[email protected]://www.amosey.com/http://www.amosey.com/mailto:[email protected]:[email protected]://www.alscanada.ca/http://www.alscanada.ca/http://www.alscanada.ca/mailto:[email protected]://www.amosey.com/mailto:[email protected]://www.acerna.ca/mailto:[email protected]


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AxSource Consulting Inc.

336 Bronte Street South

Suite 224

Milton, ON

L9T 7W6

Ms. Navneet Sekhon

President

Tel: 905-854-6059

Cell: 416-452-0100

[email protected]

www.axsource.ca

Pharmaceuticals/Sterile

Biologics

Veterinary Drugs

Medical Devices

Cosmetics

OTC


GMP,GLP,GCP & ISO

Regulatory Affairs, QA/QCClinical, Engineering,Validations incl. Software

Pre-inspection, Compliance &consultant audits

Virtual RAQA services

Canada

United States

Europe

Mexico

China

India

BNA Consultant Group

301, Dorval Av.

Dorval, Quebec

H9S 3H6

Rachid Akhiate

Tel: 514-774-1046

Fax: 514-631-3868

[email protected]

www.GBNAC.com

Medical Devices

Cosmetics



BNA CONSULTANTS is agroup of experts specialized inregulation of natural healthproducts, health supplements,foods and pharmaceuticals.BNA CONSULTANTS assistsnatural health product andpharmaceutical companies tofacilitate and guide themthrough the regulation

procedures.

Canada

Canadexlabs

725 Place Fortier #707

Montreal, Quebec

H4L 5B9

Mr. Fayez Chehab

Tel: 514-978-4466

Fax: 514-747-7550

[email protected]

www.canadexlabs.com

Pharmaceuticals

Veterinary Drugs

Medical Devices

Cosmetics



Health Canada drugsubmissions: (NDS) (SNDS)(ANDS) (NC) (DIN)

Health Canada Natural Healthproducts submissions: (NPN)

Quality Control & Qualityassurance

GMP Compliance & Productregistration

Canada

United States

Europe

Gulf Arabic States(GCC countries)
mailto:[email protected]:[email protected]://www.axsource.ca/http://www.axsource.ca/mailto:[email protected]:[email protected]://www.gbnac.com/http://www.gbnac.com/mailto:[email protected]:[email protected]://www.canadexlabs.com/http://www.canadexlabs.com/http://www.canadexlabs.com/mailto:[email protected]://www.gbnac.com/mailto:[email protected]://www.axsource.ca/mailto:[email protected]


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Dicentra

21 Phoebe Street

Toronto, ON

M5T 1A8

Peter Wojewnik

Tel: 416-361-3400

Fax: 416-361-3304

[email protected]

www.dicentra.com

Natural Health ProductsCosmetics


dicentra is an internationalleader in regulatory andscientific affairs within thenatural health product, dietarysupplement, food, beverage,cosmetic and OTC industries

Canada

United States

DSA Consultants

1660 North Service Road E.Units 106 & 107

Oakville, ON, Canada

L6H 7G3

Mark Moody

Tel: 905-827-0057 ext.229Fax: 905-827-0060

[email protected]

www.dsaconsultants.com

Pharmaceuticals


Medical Devices

Cosmetics



Regulatory Affairs, Quality

Control and Quality Assurance Product Registrations,

Establishment/Site Licensing,Liaison with Health Canada,SOP Development, GMPCompliance, Audits and more.

Canada

Emergo Group

Suite 300,

1275 West 6 Avenue,

Vancouver, BC V6H 1A6

Daryl Wisdahl

Tel: 604-909-1265

Fax: 1-888-470-2695

[email protected]

www.emergogroup.com

Medical Devices Emergo Group helps medicaldevice and IVD manufacturersobtain regulatory approval fromHealth Canada.

Canada

United States

Europe

AsiaAfrica

Australia

Latin America

Fastrack Consulting

12 Forestgrove Drive

Ottawa, ON K2S 1V2

Dr. Kathy A. Zito

Tel: 613-286-2089

Fax: 613-831-6988

[email protected]

Pharmaceuticals

Biologics

Medical Devices

Extensive scientific, productdevelopment and regulatoryexperience across multipletherapeutic areas of interest

Scientific evaluation of in vitro,preclinical and chemistry andmanufacturing data

Canada

United States

Europe
mailto:[email protected]:[email protected]://www.dicentra.com/http://www.dicentra.com/mailto:[email protected]:[email protected]://www.dsaconsultants.com/http://www.dsaconsultants.com/mailto:[email protected]:[email protected]://www.emergogroup.com/http://www.emergogroup.com/mailto:[email protected]:[email protected]:[email protected]://www.emergogroup.com/mailto:[email protected]://www.dsaconsultants.com/mailto:[email protected]://www.dicentra.com/mailto:[email protected]


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Focal Point Research Inc.

181 Lakeshore Rd. E.

Mississauga, ON

L5G 1G2

Robert Ross-Fichtner

Tel: 905-271-2709 ext. 222

Fax: 905-271-4540

[email protected]

www.focalpointresearch.ca

Cosmetics


Drugs

Medical Devices

Consumer Products

Packaging

Regulatory

Labeling & Marketing

Quality & Safety

Environment

Clinical

Due Diligence

Chemistry

Product Development

Canada

United States

Europe

GMD PharmaSolutions

1215 North Service Road W.

Oakville, ON

L6M 2W2

Sam Tarantino

Tel: 905-827-1300 ext. 137

[email protected]

www.gmdpharma.ca

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices



Controlled Substances

Regulatory Affairs

Warehouse services

Importation

Distribution

Patient Programs

Specialty Care Pharmacy

Canada

United States

Grieb Consulting(VG Solutions)

1060 de Canna

Laval, QC

H7X 3W4

Victoria GriebTel: 450-314-3545, 514-651-0465

Fax: 450-314-3585

[email protected]

PharmaceuticalsMedical Devices

Cosmetics



Food

Regulatory affairs for cosmetics,OTC drugs, NHPs

DIN,NPN applications, Medicaldevice licenses

LiaisonHealth Canada

Regulatory training

GMP, QA/QC

Packaging review

Environmental compliances

English or French, including

translations

Canada
mailto:[email protected]:[email protected]://www.focalpointresearch.ca/http://www.focalpointresearch.ca/mailto:[email protected]:[email protected]://www.gmdpharma.ca/http://www.gmdpharma.ca/mailto:[email protected]:[email protected]:[email protected]://www.gmdpharma.ca/mailto:[email protected]://www.focalpointresearch.ca/mailto:[email protected]


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Integrated TherapeuticSolutions Inc.

First Canadian Place

100 King Street W. #5600,

Toronto, ON

M5X 1C9

Dimitri Fitsialos

Tel: 416-360-0393

Fax:1-866-246-1693

[email protected]

www.integratedTSI.com

Pharmaceuticals

Biologics

Medical Devices

Regulatory

Medical writing

Pharmacovigilence

Canadian Scientific Officerservices

Clinical development

Canada

United States

Europe

Intertek Cantox2233 Argentia Rd.,

Suite 308

Mississauga, ON

L5N 2X7

Pharmaceuticals & HealthcareTel: 905-542-2900

Fax: 905-542-1011

[email protected]

PharmaceuticalsBiologics

Veterinary Drugs

Medical Devices

Cosmetics

DIN Products


Specialists in toxicologyprogram design and monitoring;comprehensive regulatorystrategies; submissionpreparation and review

Scientific writing of nonclinical,clinical and CMC data

Agency interactions

CanadaUnited States

Europe

International

International Food Focus Ltd.

211 Carlton Street

East OfficeToronto, ON

M5A 2K9

Carol T. Culhane

Tel: 416-924-3266

Fax: 416-924-2726

[email protected]

www.foodfocus.on.ca

Natural Health Products Preparation of Health Canadapre-market submissions fornovel fibres, novel foods, foodadditives, infant formula andTemporary Marketing

Authorizations

Product license applications forNatural Health Products in foodformat

Canada

United States

Europe
mailto:[email protected]:[email protected]://www.integratedtsi.com/http://www.integratedtsi.com/mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.foddfocus.on.ca/http://www.foddfocus.on.ca/http://www.foddfocus.on.ca/mailto:[email protected]:[email protected]://www.integratedtsi.com/mailto:[email protected]


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K. Friedman Consulting

537 Bedford Park Ave.

Toronto, ON

M5M 1K4

Karen Friedman

Tel: 416-783-9394

Fax: 416-783-3114

[email protected]

www.kfriedmanconsulting.com

Pharmaceuticals

Natural Health ProductsPreparation of natural health

product applications and sitelicense applications

Preparation of new andsupplemental new drugsubmissions, clinical trialapplications, notifiable changes

Preparation of DIN applications

Cosmetic regulatory affairs

Canada

MarcM Consulting Canada

172 Mausser Avenue

Kitchener, ON

N2M 3K7

Marcela Saad

Tel: 519-579-0821

Fax: [email protected]

www.marcmconsulting.ca

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics



Regulatory Strategy & MarketApplications with primary focuson the Americas

English, Portuguese, Spanishservices

Clinical trial, site license & drugapplications

GMP/GCP/ISO compliance

Post-market changes

Business development,industry-government relations

Canada

United States

Latin America

Europe

McCarthy ConsultantServices Inc.

8-1151 Gorham Street

Newmarket, ON

L3Y 8Y1

Matt McCarthy

Tel: 1-905-836-0033

Fax: 1-905-836-0006

[email protected]

www.mccarthyconsultant.com

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics



With 29 years of experience,MCSI has evolved into anindustry leading contractRegulatory Affairs ManagementOrganization

Let MCSI be your key toregulatory compliance

Canada

United States

Europe

Asia

Australia
mailto:[email protected]:[email protected]://www.kfriedmanconsulting.com/http://www.kfriedmanconsulting.com/mailto:[email protected]:[email protected]://www.marcmconsulting.ca/http://www.marcmconsulting.ca/mailto:[email protected]:[email protected]://www.mccarthyconsultant.com/http://www.mccarthyconsultant.com/http://www.mccarthyconsultant.com/mailto:[email protected]://www.marcmconsulting.ca/mailto:[email protected]://www.kfriedmanconsulting.com/mailto:[email protected]


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Natural Products ConsultingCorporation

39 Glen Rush Boulevard

Toronto, ON

M5N 2T6

Lionel Pasen

Tel: 905-763-9999

Fax:905-784-1110

[email protected]

www.npc-corp.ca

Veterinary Drugs



Consultants specializing inNHPs, OTCs, cosmetics, dietarysupplements & foods

Regulatory strategy,government negotiations,product/site licensing, claimsubstantiation, GMP compliance& operations process

management

Canada

United States

Mexico

Normand RobichaudServices conseils inc.

4025 chemin Sainte-Foy

Quebec, Quebec

G1Y 1T7

Normand Robichaud

Tel: 418-650-5628

[email protected]

www.normandrobichaud.com

Pharmaceuticals

Medical Devices

Cosmetics



Services conseils en BonnesPratiques de Fabrication (BPF)

Systmes Qualit

Audits Qualit

Conformit pour lindustriepharmaceutique, cosmtique,des biotechnologies et desproduits de sant naturels.

Canada

United States

Europe

NovaTox Inc.

10 Crane AvenueGuelph, ON

N1G 2R2

Canada

Mark Chappel

Tel: 877-680-7256Fax:519-231-0130

[email protected]

www.novatox.ca

Pharmaceuticals


Medical Devices

Cosmetics



Specialized toxicology company

with expertise in:toxicology, safety programs

dose-response

impurities

non-clinical studydesign/interpretation

Canada

United StatesEurope

Australia
mailto:[email protected]:[email protected]://www.npc-corp.ca/http://www.npc-corp.ca/mailto:[email protected]:[email protected]://www.normandrobichaud.com/http://www.normandrobichaud.com/mailto:[email protected]:[email protected]://www.novatox.ca/http://www.novatox.ca/http://www.novatox.ca/mailto:[email protected]://www.normandrobichaud.com/mailto:[email protected]://www.npc-corp.ca/mailto:[email protected]


9/18

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Nucro Technics

2000 Ellesmere Rd. #16

Scarborough, ON

M1H 2W4

John C. Fanaras

Tel: 416-438-6727

Fax: 416-438-3463

[email protected]

www.nucro-technics.com

Pharmaceuticals

Medical Devices

Cosmetics



Regulatory Affairs for cosmetics,OTCs, Drugs, NHPs

DIN, NPN, Medical Deviceapplications

Post market changes

Audits

Legal agents

Laboratory Support/pre-clinicalstudies, Genotoxicity

Canada

United States

Europe

Asia

Australia

Nutrasource Diagnostics Inc.

Suite 203

120 Research Lane

University of Guelph

Research Park,

Guleph, ON

N1G 0B4

Krista Coventry, M.Sc.

Tel: 519-341-3363

Fax: 519-341-3368

[email protected]

www.nutrasource.ca

Pharmaceuticals


Functional Food &Beverages

Foods

Medical Devices

Cosmetics

RA: Project Management

Concept to Claim Strategies

Applications(Pharmaceuticals/NHPs/MedDevices/Foods)

Pharmaceutical Development ofNHPs (Farm to Pharm)

Facility Compliance(GMP/SOPs)

Clinical Trial Design,Implementation, Monitoring

Canada

United States

Optuminsight (formerlyCanReg Inc.)

4 Innovation Drive

Dundas, ON

L9H 7P3

Darrell Ethell

Tel: 905-689-3980

Fax: 905-689-1465

[email protected]

www.optuminsight.com/srs

Pharmaceuticals

Biologics

Medical Devices

Cosmetics



One-stop global regulatorysolution for companies of allsizes and stages ofdevelopment

More than 100 in-houseconsultants and staff serveclients

Canada

United States

Europe

Asia

Africa

Australia

Latin America
mailto:[email protected]:[email protected]://www.nucro-technics.com/http://www.nucro-technics.com/mailto:[email protected]:[email protected]://www.nucro-technics.com/http://www.nucro-technics.com/mailto:[email protected]:[email protected]://www.optuminsight.com/srshttp://www.optuminsight.com/srshttp://www.optuminsight.com/srsmailto:[email protected]://www.nucro-technics.com/mailto:[email protected]://www.nucro-technics.com/mailto:[email protected]


10/18

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Peter Jeffsand Associates Inc.

P.O. Box 73024,

RPO Legget

Kanata, ON

Canada

K2K 3C5

Peter Jeffs

Robert Jeffs

Dr. Scott Boyd

Tel: 613-839-0001

Fax:613-839-1704

[email protected]

www.pja-inc.com

Pharmaceuticals

Biologics

Veterinary Drugs

Peter, former director of theBureau of PharmaceuticalQuality has 30 years experienceat Health Canada

PJA, providing Chemistry andManufacturing regulatory adviceand expertise since 1996

Canada

United States

Europe

Pharmaffair Inc.

52 Sandfield Rd.

Toronto, ON

M3B 2B7

Maha Tawashi

Tel: 416-444-8090

Fax: 416-444-4246

[email protected]

www.pharmaffair.ca

Pharmaceuticals

Biologics

Medical Devices

Cosmetics



RA: New product submissions

Regulatory strategy

Government liaisons

Labeling and advertising

Pharmacovigilence

Product development

QA/QC

GMP

Canada

PharmEng Technology

3760 14thAvenue, Suite 201Markham, ON

L3R 3T7

Ben Lee

Tel: 905-415-3922Fax: 905-415-3966

[email protected]

www.pharmeng.com

Pharmaceuticals

BiologicsVeterinary Drug

Medical Devices

Cosmetics



Commissioning & Qualification

ValidationQuality Systems

Regulatory Affairs

Engineering

Training

Canada

United StatesEurope

Asia
mailto:[email protected]:[email protected]://www.pja-inc.com/http://www.pja-inc.com/mailto:[email protected]:[email protected]://www.pharmaffair.ca/http://www.pharmaffair.ca/mailto:[email protected]:[email protected]://www.pharmeng.com/http://www.pharmeng.com/http://www.pharmeng.com/mailto:[email protected]://www.pharmaffair.ca/mailto:[email protected]://www.pja-inc.com/mailto:[email protected]


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Proficio Scientific Affairs Inc.

3700 St-Patrick

Suite 240

Montreal, Quebec

H4E 1A2

Simon Alexander

Tel: 514-296-0125

Fax: 514-933-7208

[email protected]

www.proficioconsult.com

Pharmaceuticals

Biologics

Veterinary Drug

Medical Devices



Expert Regulatory Support for:

Clinical Trials (devices, drugs,biologics)

Product Registration

Health Authority Meetings &Negotiations

Post-market & Life-cycle

management20 years regulatory affairs &

development experience

Canada

Quality & ComplianceServices Inc.

9-6975 Meadowvale TownCentre, Suite 410

Mississauga, ON

L5N 2V7

Stephen Semple

Tel: 905-363-1182, ext.210

Fax: 905-542-7981

[email protected]

www.qualityandcompliance.com

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics



Q &C s full-time consultantsprovide complete regulatory,quality control and complianceservices for the pharmaceutical,natural health product, cosmeticand medical device industriesand their suppliers.

Canada

United States

Europe

Asia

Australia

Latin America

RaQa Consulting Inc.

7536 Bath Road

Mississauga, ON

L4T 1L2

Mia Spiegelman

Sandra Ireland

Tel:1-866-697-7272

[email protected]

www.raqaconsulting.ca

Medical Devices

Cosmetics

Drugs


Foods

Complete Business Solutionsand Project Management forManufacturing/Importing anddistributing Medical Devices,Cosmetics and NHPs in theCanadian market.

Canada

United States
mailto:[email protected]:[email protected]://www.proficioconsult.com/http://www.proficioconsult.com/mailto:[email protected]:[email protected]://www.qualityandcompliance.com/http://www.qualityandcompliance.com/mailto:[email protected]:[email protected]://www.raqaconsulting.ca/http://www.raqaconsulting.ca/http://www.raqaconsulting.ca/mailto:[email protected]://www.qualityandcompliance.com/mailto:[email protected]://www.proficioconsult.com/mailto:[email protected]


12/18

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Redstone Health Group Inc.

2125 Galena Crescent

Oakville, ON

L6H 4A9

Karen Feltmate

Tel: 905-842-4230

Fax: 905-338-8970

[email protected]

www.rdstonehealthgroup.com

Pharmaceuticals


Redstone will help you todevelop regulatory strategies forsuccessful Federal registration,Provincial listing and ultimatelydrive brand performance andbusiness growth

Canada

Regxia Inc.

5-133 The West Mall

Toronto, ON

M9C 1C2

Betty Cory

Tel: 416-620-5236

Fax: 416-620-0261

[email protected]

www.Regxia.com

Pharmaceuticals

Biologics

Medical Devices


Regxia is a unique scientific andregulatory consulting firm with aprimary focus of collaboratingwith our customers

We provide knowledge,experience and innovation

Canada

United States

Europe

Australia

RegPharm Consulting Inc.

Montreal, Quebec

Katia Betito, Ph.D.

Tel: 514-817-4424

[email protected]

Pharmaceuticals

Medical Devices



Cosmetics

Preparation of clinical andquality sections of regulatorysubmissions

Strategic guidance

Regulatory training

Over 15 years of experience ingeneric (parenterals) andbranded product registration

Canada

RS Consultant Services

1 Ardwold Gate

Richmond Hill, ON

L4B 2J9

Ram Srivastava

Tel: 905-918-0272

Fax: 905-237-0322

[email protected]

www.rsconsultantservice.com

Medical Devices


Pharmaceuticals

Biologics

Cosmetics

Pest Control Products

Consulting in Medical Devices,Natural Health Products,Pharmaceuticals, Biologics,Cosmetics and Pest ControlProducts.

Offering regulatory and qualityservices for Canada, U.S.A. and

Europe

Canada

United States

Europe
mailto:[email protected]:[email protected]:[email protected]://www.rdstonehealthgroup.com/http://www.rdstonehealthgroup.com/mailto:[email protected]:[email protected]://www.regxia.com/http://www.regxia.com/mailto:[email protected]:[email protected]:[email protected]:[email protected]://www.rsconsultantservices.com/http://www.rsconsultantservices.com/http://www.rsconsultantservices.com/mailto:[email protected]:[email protected]://www.regxia.com/mailto:[email protected]://www.rdstonehealthgroup.com/mailto:[email protected]:[email protected]


13/18

13




Services PharmaceutiquesMD inc

115-B Vaudreuil

Boucherville, Qubec

J4B 1K7

Melvin Dionne

Tel: 1-866-454-8209

Fax: 450-641-2206

[email protected]

www.spmd.ca

Cosmetics



Application pour NPN, DIN

Service dassurance qualit,cours de formation BonnesPratiques de Fabrication(BPF,GMP), demande etrenouvellement de licencedexploitation, rdaction deprocdures BPF (GMP)

Canada

SMI- Solutions

50 Alliance Blvd.

Barrie, ON

L4W 5K3

Tish Anger

Tel: 705-720-1902

Fax: 705-728-9537

[email protected]

www.smi-solutions.com

Medical Devices

Canada

United States

Europe

Source Nutraceutical, Inc.

11249 Clarence Avenue

Winnipeg, Manitoba

R3T 1T4

Bernie Desgagnes

Tel: 204-254-2234

Fax: 204-254-7817

[email protected]

www.sourcenutra.ca

Pharmaceuticals

Veterinary Drugs

Medical Devices

Cosmetics



Your one-stop-solution forregulatory compliance, graphicdesign, bilingual labeling andimportation and fulfillment

services for foods, naturalhealth products, cosmetics,medical devices andpharmaceutical products.

Canada

United States

Spectrum MMC

475 Westminster Avenue

Dollard-des-Ormeaux,(Montreal) Quebec

H9G 2S3

Wayne Bryant

Tel: 514-696-0303

Fax: 514-696-0373

[email protected]

www.SpectrumMMC.com

Pharmaceuticals

Biologics

Medical Devices

Cosmetics



20 year track record indelivering strategic and qualityturnkey services in regulatory,scientific, clinical affairs,pharmacovigilance andmarketing to companies rangingfrom start-ups to multinationals.

Canada

United States

Europe

Asia

Australia

Latin America
mailto:[email protected]:[email protected]://www.spmd.ca/http://www.spmd.ca/mailto:[email protected]:[email protected]://www.smi-solutions.com/http://www.smi-solutions.com/mailto:[email protected]:[email protected]://www.sourcenutra.ca/http://www.sourcenutra.ca/mailto:[email protected]:[email protected]://www.spectrummmc.com/http://www.spectrummmc.com/http://www.spectrummmc.com/mailto:[email protected]://www.sourcenutra.ca/mailto:[email protected]://www.smi-solutions.com/mailto:[email protected]://www.spmd.ca/mailto:[email protected]


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14




SPEK RegulatoryConsultants

4080 Farnsworth Cres.

Mississauga, ON

L5L 3Z3

Sunita Phull / Ella Dratewka-Kos

Tel: 647-234-4930 / 416-560-6637

Fax: 416-223-9875

[email protected]

www.spek-consulting.com

Pharmaceuticals

Biologics



With 40+ years of combinedexperience, we provide:

Regulatory advice

Preparation of marketregistration dossiers includingpost NOC changes,Establishment/Site Licences

Regulatory support for clinicaltrial activities (Pre-submissionmeetings, CTAs,GCPinspections)

Canada

SPharm Inc.

1235, 3rdAvenue

Val-dOr, Quebec

J9P 6C3

Sabrina Turgeon

Tel: 819-824-6869

Fax: 819-824-4876

[email protected]

[email protected]

Pharmaceuticals

Biologics

Veterinary Drugs

Medical Devices

Cosmetics


Natural Health ProductsFood and Feeds

Product development

Regulatory affairs in NorthAmerica

Medical Writing

Submission strategy

Meeting preparation and liaisonwith Health Authorities

eCTD

Canada

United States

Europe

SpringBoard Solutions Inc.

1332 Nocturne Court

Mississauga, ON

L5H 2L8

Sheila Garven

Tel: 416-619-9025

[email protected]

www.springboardsolutions.ca

Pharmaceuticals

BiologicsRegulatory support in the filing

and approval of drugsubmissions

Development of position paperson regulatory policy issues

Provide affidavits and testimonyin patent cases

Canada
mailto:[email protected]:[email protected]://www.spek-consulting.com/http://www.spek-consulting.com/mailto:svaralo@spharm./cahttp://www.spharm.ca/mailto:[email protected]:[email protected]://www.springboardsolutions.ca/http://www.springboardsolutions.ca/http://www.springboardsolutions.ca/mailto:[email protected]://www.spharm.ca/mailto:svaralo@spharm./cahttp://www.spek-consulting.com/mailto:[email protected]


15/18

15




Stan North Consultation

4611 Harvard Ave.

Montreal, Quebec

H4A 2X3

Stan North, M.Sc.

Tel: 514-577-5913

[email protected]

www.StanNorthConsultation.com

Pharmaceuticals

Biologics

Medical Devices



Cosmetics

Regulatory consulting for thepharma, medical device andbiotech sectors

Clinical and CMC submissions

CTAs

Project management

Product monographs andlabeling

Regulatory guidance andstrategy

We offer quality service,flexibility and customer-focuswith over 16 years of industryexperience

Canada

SYLLA CONSEILS INC.

2149 Lincourt

Longueuil, Quebec

J4N 1N8

Sylvie Lachance

Tel: 450-332-0928

Cell:514-823-0928

Fax:450-332-0928

[email protected]

Pharmaceuticals

Veterinary Drugs

Medical Devices

Cosmetics



Regulatory Affairs

DIN,NPN applications & Medicaldevice 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

Canada

United States

Europe
mailto:[email protected]:[email protected]://www.stannorthconsultation.com/http://www.stannorthconsultation.com/mailto:[email protected]:[email protected]://www.syllaconseils.com/http://www.syllaconseils.com/http://www.syllaconseils.com/mailto:[email protected]://www.stannorthconsultation.com/mailto:[email protected]


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THT Health Communications

15 Woodend Drive

Carlisle, ON

L0R 1H2

Tracy Howard-Tripp, M.Sc.

Tel: 905-690-9746

Fax: 905-690-9665

tracy.howardtripp@sympatico.cawww.medicalregulatoryconsulting.com

Pharmaceuticals

BiologicsStrategic RA expertise in pre-

market and post-marketapplications

Specialized medical writingproficiency in preparation ofdocuments for productdevelopment (i.e. clinical trialprotocols, IBs, CSRs, PMs and

clinical summaries

Canada

W. Harvey Regulatory and

Writing Service, Inc.

18 Windham Trail

Aurora, ON

L4G 5M3

William Harvey

Tel: 905-713-0920

[email protected]

Pharmaceuticals

BiologicsRegulatory submissions for

clinical trial and marketingapplications including chemistryand manufacturing,pharmacovigilance andestablishment licenses.

Preparation of briefingdocuments, submissionsummaries, clinical studyprotocols and reports

Canada
mailto:[email protected]:[email protected]://www.medicalregulatoryconsulting.com/http://www.medicalregulatoryconsulting.com/mailto:[email protected]:[email protected]:[email protected]://www.medicalregulatoryconsulting.com/mailto:[email protected]


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List of Consultants

The list comprises consulting companies whose primary focus is Regulatory Affairs, Clinical Research, Quality Control or Compliance (GCP, GLP, GMP) forpharmaceuticals, biologics, veterinary drugs, medical devices, cosmetics, over-the-counter products, or natural health products. Companies are listedalphabetically 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 PracticesNHP = Natural Health Product

QA = Quality Assurance

QC = Quality Control

RA = Regulatory Affairs

SOP = Standard Operating Procedures

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.


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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 theinformation on the list for presentation in a standard format. CAPRA / ACPR does not endorse any of the consultants on the list.

Consultants - Copy

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