Solutions: Regulatory Compliance

Helping to navigate the regulatory landscape, from working closely with the CRO pre-approval to ensuring all Good CGMPs regulations are met post launch.

Agency Reporting
We ensure that all regulatory safety reporting requirements are met, and that any new and amended reporting requirements are incorporated into our reporting procedures for the product.

Medical Affairs
We provide medical affairs leadership to meet operational and regulatory challenges, including professional communications, safety reporting, and the clinical aspects of marketing and sales.

Corporate Compliance
We codify and implement professional standard operating procedures for all aspects of the commercialization, sales, and distribution of your product to ensure compliance.