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TPIreg | Navigating Regulatory Affairs

Therapeutic Products Inc. is a company of Regulatory Affairs Consultants, founded by Anne Tomalin, BA, BSc. Regulatory Affairs. We are dedicated to North American Regulatory Affairs Consulting services for the pharmaceutical, biotechnology and natural health products industries.

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Matthew French

303-170●●●●●●●man Ave

Bur●●●ton , ON, L7L 6R8

CANADA

1905●●●●7495
un●●●●●●●●@hotmail.com

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Matthew French

303-170●●●●●●●man Ave

Bur●●●ton , ON, L7L 6R8

CANADA

1905●●●●7495
un●●●●●●●●@hotmail.com

View this contact

Matthew French

303-170●●●●●●●man Ave

Bur●●●ton , ON, L7L 6R8

CANADA

1905●●●●7495
un●●●●●●●●@hotmail.com

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TPIreg | Navigating Regulatory Affairs | tpireg.com Reviews

https://tpireg.com

Therapeutic Products Inc. is a company of Regulatory Affairs Consultants, founded by Anne Tomalin, BA, BSc. Regulatory Affairs. We are dedicated to North American Regulatory Affairs Consulting services for the pharmaceutical, biotechnology and natural health products industries.

INTERNAL PAGES

tpireg.com tpireg.com
1

D.I.N. Application | TPIreg

http://www.tpireg.com/din-application.php

A Drug Identification Number (DIN) is an eight (8) digit numerical code assigned to each drug product marketed under the Food and Drugs Act and Regulations. DIN Submissions outlines the information normally needed to establish quality, safety and efficacy of drug products according to product type. With our many years of regulatory experience our staff can assist you with successful filings of DIN Applications and strategic consulting needs. Website Design and Development by Virtual Image, Hamilton.

2

Our Team | TPIreg

http://www.tpireg.com/our-team.php

Our senior consultants have extensive backgrounds and many years of experience working with Health Canada, the FDA and other regulatory agencies on regulatory, clinical and quality matters. Anne Tomalin, BA, B.Sc., President. John Wong, M.Sc.Pharm., Executive Director, Regulatory Drug Advertising and Promotion. Brenda Gryfe, M.Sc.Phm., Director, Regulatory Affairs. Michelle De La Croix, RAC, Senior Director, Regulatory Affairs. Krystyna Bienkiewicz, B.Sc., Director, Regulatory Affairs. Previously from Ca...

3

North American Regulatory Services | TPIreg

http://www.tpireg.com/north-american-regulatory-services.php

North American Regulatory Services. Being a Canadian Company, we are proud of our collective experience with all Directorates at Health Canada. Our services include:. Label and advertising review for compliance. Product review and feasibility. Clinical Trial Applications/Investigation New Drug Submissions. Drug Establishment License Applications. Drug Identification Number Submissions (DINs). Medical Device Applications/Premarket Notifications 510(k), Premarket Approvals (PMA). New Drug Submissions (NDS).

4

New Drug Submissions | TPIreg

http://www.tpireg.com/new-drug-submissions.php

A “new” drug is defined in Canadian Food and Drug Regulations as a drug that contains or consists of a substance (whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component), which has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug. Supplemental New Drug Submission (SNDS);. Supplement to an Abbreviated New Drug Submission (SANDS). With our m...

5

Quality Assurance | TPIreg

http://www.tpireg.com/quality-assurance-services.php

Our TPIreg QA team offers quality consultation. On quality assurance and GMP services for drug products, natural health products, cosmetics and food. With a combined service record of over 40 years our quality assurance specialists can help you navigate through Health Canada requirements to optimize your commercial quality activities. Our team of experts can guide you through:. Full Canadian QA Representation. Release of Commercial Drug Product to Canadian/US Market. Natural Health Products (Canada).

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ohcanadaribfest.ca ohcanadaribfest.ca

Ribfest Admin

http://www.ohcanadaribfest.ca/author/sue-collins

Volunteer At Ribfest 2016. Oh Canada Ribfest: Big Ribfest - Small town feel. June 30 - July 3, 2016. Waterdown Business Village VIP Tent. Dream Centre Family Fun Zone. Headliner and Specialty Sponsors. 2016 Gold/Silver/Bronze Sponsors/Friends of Ribfest. Hospitality & Media/In-kind Partners. Rotary Marketplace Courtesy of Brown Lawyers. Become a Food Vendor. Become a Non-food vendor. Boss Hogs sweeps the board. July 4, 2016. Last day of Oh Canada Ribfest 2016. July 3, 2016. Winding up but not winding down.

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News

http://www.ohcanadaribfest.ca/news

Volunteer At Ribfest 2016. Oh Canada Ribfest: Big Ribfest - Small town feel. June 30 - July 3, 2016. Waterdown Business Village VIP Tent. Dream Centre Family Fun Zone. Headliner and Specialty Sponsors. 2016 Gold/Silver/Bronze Sponsors/Friends of Ribfest. Hospitality & Media/In-kind Partners. Rotary Marketplace Courtesy of Brown Lawyers. Become a Food Vendor. Become a Non-food vendor. Boss Hogs sweeps the board. July 4, 2016. Last day of Oh Canada Ribfest 2016. July 3, 2016. Winding up but not winding down.

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TPIreg | Navigating Regulatory Affairs

Our staff provides quality assurance and Good Manufacturing Practices (GMP) services in order to conform to the guidelines recommended by government agencies for drug products, natural health products, cosmetics and food. Services include Importer of Record, release of commercial drug product to the Canadian market, and GMP audits. North American Regulatory Services. We offer webinars and custom courses for industry of all sizes. Check back frequently to see our latest offerings. Therapeutic Products Inc...

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