REGULATORY AFFAIRS SUPPORT SERVICES

TITLE REGULATORY AFFAIRS SUPPORT SERVICES DESCRIPTION PWGSC intends to award a contract for the provision of a regulatory affairs and product development specialist team to prepare and file regulatory submissions to meet Health Canada (HC) regulations for drugs, biologics and medical devices on behave of the Department of National Defence (DND) The resulting contract is for a period of 3 years, with 2 additional, 1 year option periods, and a 6 month optional transitional period. There is no security requirement associated with this requirement. Bidders must provide a list of names, or other related information as needed, pursuant to section 01 of Standard Instructions 2003. For services requirements, Bidders in receipt of a pension or a lump sum payment must provide the required information as detailed in attachment 3 of Part 5 of the bid solicitation. The requirement is limited to Canadian goods and/or services. Canada will own the Intellectual Property Rights in the Foreground Information. This procurement is subject to the Agreement on Internal Trade (AIT) "There is a Federal Contractors Program (FCP) for employment equity requirement associated with this procurement; see Part 5 - Certifications, Part 7 - Resulting Contract Clauses and the attachment named Federal Contractors Program for Employment Equity - Certification.” TECHNICAL EVALUATION CRITERIA Mandatory and point rated technical criteria. BASIS OF SELECTION Highest Combined Rating of Technical Merit (60%) and Price (40%) and meeting all other requirements of the bid solicitation. CONTRACTING AUTHORITY Joseph Hulse Supply Specialist Public Works and Government Services Canada Science Procurement Directorate Place du Portage III, 11C1 11 Laurier Street Gatineau, Québec K1A 0S5 Phone: (873) 469-4823 Fax: (819) 997-2229 Email: Joseph.hulse@tpsgc-pwgsc.gc.ca All enquiries must be submitted in writing to the Contracting Authority no later than 5 calendar days before the bid closing date.