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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


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


Bionical Emas Regulatory Affairs: Mutual Recognition Submission Strategy