Regulatory team members 

Focused on results

154+ clinical trial applications
50+ commercial applications (BLA/MAA/NDA)

100+ product registrations

Health authority interaction worldwide

60+ experts worldwide

Expertise with worldwide regulatory authorities

We have extensive experience with the interpretation of guidance in innovative and emerging markets
Our Promise

Your success is our success

Working at PC in Stuecki offices

Reduce the time and cost impact

Our team is aligned with manufacturing sites around the world and experienced in CMC dossier preparation. We excel in writing and facilitating responses to questions raised by global health authorities for clinical trial and license applications.

Regulatory advice

We exchange information with product development, formulation, tech transfer and manufacturing daily.

We provide support with drug products developed and manufactured by us, access to regulatory information for our media, capsules and DMFs or CEPs to aid your submission.

Dedicated regulatory affairs CMC contact

We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.

Keep pace with regulatory thinking

Our regulatory affairs services communicate transparently keeping you continuously informed from the initial project kick-off meeting and subsequent interactions to facilitate any CMC development strategy or detailed discussions.