REGMEDICAL provides pharmaceutical regulatory expertise to drug companies for their 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.
Consulting services in a wide variety of subjects within pharmaceutical regulatory affairs supporting product development and registration for the entire range of 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, even NHPs; within multiple therapeutic fields such as Cardiovascular/Metabolic, Respiratory, CNS/Pain Management, Rheumatology/Anti-Inflammatory/Anti-Infectives, Dermatological, Ophthalmologic and various Rare/Orphan Diseases.
Conduct 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.). Internationally, REGMEDICAL can also provide support for pre-IND and IND submissions.
Support and develop strategies for successful interactions with Health Canada:
-Therapeutic Products Directorate,
-Marketed Health Products Directorate,
-Natural and Non-prescription Health Products Directorate
-Medical Devices Directorate
-Special Access Programme,
-Office of Risk Management
-Health product Compliance Directorate
Business Development activities such as execution of scientific review of product documentation and Due Diligence and regulatory pathway assessment for product acquisition, in-licensing, joint-venture, partnerships.
Whether the client is a small or medium size pharmaceutical company without any Canadian regulatory affairs capabilities or an enterprise having internal regulatory affairs functions, where specialized guidance and advice is required, REGMEDICAL can bring valuable organizational insight and critical regulatory/scientific input toward the achievement of desired goals.
REGMEDICAL also can offer the services of additional Regulatory Affairs specialists.