SERVICES:
Regulatory

We offer a range of regulatory services and our philosophy is to work with you early in the development process in order to build a solid foundation leading to efficient global regulatory submission and approval.

Our services include:

•   Agency meetings and negotiation (FDA, EMEA, EU and
     non-EU Competent Authorities)
•   Obtaining Orphan Drug Designation
•   Development of Paediatric Investigation Plans
•   Clinical Trial Approval (CTA)
•   Preparation of IMPDs
•   IND preparation
•   Preparation of CTD modules 1.8.1 (Detailed Description of the
     Pharmacovigilance System) and 1.8.2 (Risk Management Plan)
•   Preparation of the Clinical Overview and Clinical Summary
•   Regulatory Document Management
•   Building the eCTD submission and regulatory publishing