REGMEDICAL provides New Drug Submission (NDS) package preparation and submission, sNDS submissions, pre-NDS meetings/negotiations with Health Canada, Product Monograph development and negotiations, Product Label development/updates, development of product safety and/or clinical review documents, RMPs, submission of Clinical Trial Application, Medical Device-License Application packages.
REGMEDICAL also provides Medical Research/Scientific Information Management and Business Development / Due Diligence expertise to the pharmaceutical industry players.
- Product development regulatory and clinical activities for a variety of product types (oral formulations, injectable solutions, topical creams/ointments/gels/lotions, sterile eye drops, Inhaled solutions, medical devices, etc.) for both New Rx Drugs and DIN-OTCs, NHPs
- Negotiations with Health Canada prior and during review of drug/device submission dossiers (pre-NDS, CTA-filings and pre-filing meetings, NODs, NON reversals, NOC-with Conditions, NOC post-approval commitments, RMPs, Medical Device License
Applications, etc.)
- Business Development: Execution of scientific review of product documentation, Due Diligence and regulatory pathway assessment for product acquisition, in-licensing, joint-venture, partnerships.