Identification of applicable regulatory requirements, market and customer drivers
Development of regulatory strategy and submissions to Health Canada
Compliance Assurance Process implementation
Direct access to on-call regulatory/consulting support
Regulatory and research Q&A style support
Product classification and label development
Advertisement review in conjunction with the Pharmaceutical Advertising Advisory Board
Monthly reports on health requirements, including the impact on patients
Real-time Information Change Notices (INCs) on important changes to health requirements
Substantiating waiver requests and read-across arguments
Clinical trial submissions
Providing product safety and efficacy evaluations along with developing Risk Management Plans
Conducting human health and environmental risk assessments and evaluations of unique chemical hazards
Third-party technical liaison
Any other related regulatory services required for your products