Regulatory Affairs
Regulatory Affairs
Avoid costly compliance roadblocks
We help you navigate the increasingly complex and ever-changing regulatory labyrinth in order to eliminate surprises and meet your key milestones on time and on budget. This way, you can enjoy peace of mind and focus on that at which you really excel.
Worldwide regulatory compliance
We are fortunate to work with a global network of some of the most competent local experts to ensure that neither the local language nor specific local protocols become an obstacle.
Our regulatory experts continuously monitor country-specific regulatory and ethics restrictions and requirements and liaise with all relevant stakeholders so that submissions are always fully compliant.
Meet the regulatory authorities
We support and accompany you to meetings with international, national and regional regulatory authorities (FDA, EMA, MHRA, AIFA, AEMPS, Swissmedic etc.) in order to discus applications (CTA/IND), protocols or data obtained from previously conducted trials.
Some of our services include:
- Gap analysis & IMPD/IB writing
- CMC support for Drug Substances (NCE, biologic, biosimilar…) and Drug Product
- Pre-clinical protocol & report review (analytical methods, impurity characterization)
- Regulatory Authorities meetings (EMA, FDA, country-specific)
- Applications:
- Clinical Trial Authorisations (CTA/ IND)
- Orphan Medicinal Product Designation
