Focused on results
154+ clinical trial applications
50+ commercial applications (BLA/MAA/NDA)
100+ product registrations
Health authority interaction worldwide
60+ experts worldwide
Our Regulatory Services
Regulatory Affairs CMC Services for Small Molecules
Biologics Regulatory Services
Expertise with worldwide regulatory authorities
We have extensive experience with the interpretation of guidance in innovative and emerging markets
Your success is our success
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.
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.