Canadian Pharmaceutical Regulatory Affairs Consultant Including Dietary Supplements and Natural Health Products

Technical Consultant #1659

Performing key pre approval and post approval activities for drugs intended for the Canadian marketplace.
Preparation of DIN applications for submission to Health Canada.
Product license and site license applications and amendments for natural health care products.
Drug establishment licenses for Canadian importers, packagers and distributors.
Responses to Health Canada deficiency notices.

Expert Witness

Independent Consultant, President, 2003 - Present

Canadian pharmaceutical regulatory affairs and services.

Compiling product license applications and site license applications for natural health products.
Compiling new drug submissions, supplemental new drug submissions and DIN applications.
Clinical trial applications and notifiable changes for Health Canada.
Managing Access to Information (ATI) requests by third parties.
Coordinating appeals of Health Canada decisions, providing complete responses to Health Canada deficiency notices within given deadline.

Ferring Inc., Manager, Regulatory and Technical Affairs, 1994 - 2002

Pre approval activities for pharmaceuticals.
Coordinated and moderated any necessary NDS and IND-related Health Canada meetings, including relevant follow-up activities.
Compiled complete NDSs and S/NDSs for products in therapeutic areas of urology, gastroenterology, infertility, obstetrics and gynecology which allowed for successful marketing of numerous pharmaceuticals/biologics of various dosage forms.
Provided complete responses to all deficiency notices (clarifaxes, notices of deficiency/non-compliance) within given deadlines resulting in continuation of scientific review of all files.
Organized all activities related to appeals of Health Canada's decision to withdraw files, including securing and moderating Level 1 and Level 2 appeal meetings.

Post Approval Activities

Handled all Access to Information (ATI) requests by purging all information classified as trade secret information to prevent third parties from obtaining this information through ATI requests.
Submitted and received approval for all notifiable changes for marketed products (such as change in formulation, change in manufacturing location) during the life-span of products.
Submitted and received approval for all clinical S/NDSs, including changes to dosing, and addition of alternative indications/routes of administration.
Compiled and received approvals for CTAs for marketed products seeking additional indications.
Provided complete submissions to all provincial governments and secured listings on their formularies, for several products.
Successfully registered updates to provincial governments regarding product changes, such as formulation changes or change in manufacturer.

Procter and Gamble, Manager, Regulatory Affairs, 1992 - 1994

Reporting to Team Leader for Oral/Gl Care.
Submitted and received approval for DIN submissions for OTC products.
Submitted and received approval for changes to marketed products; such as label claims and revised dosing.

Novopharm Ltd., (TEVA), Regulatory Affairs Associate, 1990 - 1992

Preparation of complete generic NDSs for parenteral pharmaceuticals in therapeutic area of antibiotics and antineoplastics and related product master files on behalf of foreign raw material suppliers.
Provision of complete responses to notices of deficiencies from Health Canada for all parenteral new drug submissions.

Academic and Professional Affiliations