Regulatory Affairs

The Medicinal Products Regulatory team specializes in regulatory affairs related to bio and non-bio medicinal products. They ensure compliance with regulatory requirements for the development, registration, and lifecycle management of pharmaceutical products. Regulatory professionals collaborate with internal and external stakeholders to navigate regulatory landscapes and ensure the timely and compliant availability of these products.

The Medical Device Regulatory team focuses on regulatory affairs for medical devices, both in vitro and non-in vitro. They navigate the complex regulatory landscape governing medical devices, ensuring compliance with regulations and standards. Regulatory professionals collaborate with cross-functional teams to support the development, registration, and post-market activities of medical devices.

The R&D Regulatory Strategy/Drug Development team plays a crucial role in developing regulatory strategies for drug development and clinical trials. They navigate regulatory requirements, provide guidance on study design, and facilitate the preparation and submission of regulatory documents. Regulatory professionals collaborate closely with R&D teams to ensure compliance with regulations and ethical standards throughout the drug development process.

The Plasma Regulatory team focuses on regulatory affairs specific to plasma-derived products. They navigate regulatory requirements related to plasma collection, processing, and the manufacturing of plasma-derived therapies. Regulatory professionals collaborate with internal and external stakeholders to ensure compliance with regulations and standards specific to plasma-based products.