Get in touch
Website Logo

Regulatory Affairs

Our world-class Regulatory Team work to realize your product asset value by providing a customized, high-quality service with a focus on successfully delivering shortened development pathways and improved access for patients.

Knowledge, innovation, delivery

Our Regulatory Team has been responsible for numerous successful submissions to major competent authorities and regulatory agencies and has navigated through the complexities of EU Clinical Trial Regulation providing strategic support to our sponsors for optimal operational delivery. Our skilled teams develop high-quality written documents that are compliant with global and national regulatory requirements.

‘Successfully delivering shortened development pathways and improved access for patients.’

Case studies

Effective Pharmacovigilance & Regulatory EU and Australian Due Diligence, leading to operational and consultative support

A collaboration with US-based SME biotech client to recognize the full potential of their products, offering a significant therapeutic advantage to patients.

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

Bionical Emas Regulatory Affairs: Mutual Recognition Submission Strategy

Supporting our client to expand their commercial footprint in Europe.

Case Studies