Pharmaceutical & BioTech

A clinical-stage biotechnology company, focused on the discovery and development of small-molecule medicines.

• RPN provided local integrated support and functions for Regulatory Affairs/ Promotional Compliance/ Pharmacovigilance/ Medical Information, facilitating maintenance of medicinal products.
• Ensured compliance with local regulatory requirements through collaboration with company departments and local roles.
• Delivered a fully integrated and experienced function, enhancing the client’s local market operations.

The company faced challenges in maintaining local Regulatory Affairs, Promotional Compliance, Pharmacovigilance, and Medical Information for its medicinal products. This included managing local regulatory requirements for maintenance and commercialization, and ensuring all local requirements were assessed and executed effectively.

RPN provided local integrated support and functions, assisting in the management of local regulatory requirements and ensuring seamless collaboration with all relevant company departments. We helped in the appointment and coordination of local roles such as the local Scientific Service, local Pharmacovigilance and Regulatory Affairs contact to liaise with the Authorities and to ensure that local regulations and standards were accurately adhered to.

With RPN’s support, the client experienced a robust and efficient local operation, with fully integrated and experienced functions and roles. This resulted in improved maintenance and commercialization of their medicinal products in local markets, with assured compliance and enhanced collaboration across departments. The client benefited from RPN’s flexibility and depth of expertise, which provided the necessary support for success in their endeavors.