Regulatory Strategies to secure successful outcomes for Pharmaceutical Companies and Partners

Pharmaceutical regulatory affairs 

• Supporting product development and registration

• 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;

• Within multiple therapeutic fields such as Cardiovascular/Metabolic, Respiratory, CNS/Pain Management, Rheumatology/Anti-Inflammatory/Anti-Infectives, Dermatological, Ophthalmologic and various Rare/Orphan Diseases

• 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.)

Regulatory Agency Interactions

• Support and develop strategies for successful interactions with Health Canada:

o Therapeutic Products Directorate,

o Marketed Health Products Directorate,

o Natural and Non-prescription Health Products Directorate

o Medical Devices Directorate

o Special Access Programme,

o Office of Risk Management

o Health product Compliance Directorate

Business Development

• Execution of scientific review of product documentation

• Due Diligence and regulatory pathway assessment for product acquisition, in-licensing, joint-venture, partnerships.

• Services of additional Regulatory Affairs specialists who supplement their own expertise in closely related fields

Medical Research/Scientific Information Management

• Execution of scientific review of product documentation (pre-clinical, clinical data, etc.)

• Medical writing

• Review of Medical literature

• Medical Information services

• Pre- and post-approval, post-marketing Risk Management Plans (RMPs)