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Regulatory Affairs

Our world-class Regulatory Team work to provide expertise in the evolving Early Access Program (EAP) landscape by providing a customized, high-quality service with a focus on advising on strategic regulatory advice to successfully deliver improved access for patients.

Knowledge, innovation, delivery

Our Regulatory Team has been responsible for the set up and management of global EAPs, completing numerous successful submissions to major competent authorities and regulatory agencies. We strive to provide strategic support to our sponsors for optimal operational delivery. Our skilled team develop high-quality written documents that are compliant with global and national regulatory requirements.

‘We provide strategic support to our sponsors for optimal operational delivery’

Case studies

Global EAP for a specialized biotech company

Requirement for a global EAP of a rare disease on behalf of a US biotech partner.

Case Studies

European EAP with tailored RWD strategy

Rapid set-up of EAP for a rare oncology product.

Case Studies

Supplying our top 10 US pharma client with local language comparator and ancillary product

Locally sourcing, storing and distributing comparators and ancillaries for a global phase 3 study.

Case Studies