Pharma Regulatory Services

Our experienced Regulatory professionals keep track of the constant development of Pharma and MedTech legislations across the world. We give advice on restraints and requirements and help client to choose the right strategy and procedure.

We package the registration documents for submission and carry out the negotiations necessary to obtain and maintain marketing authorisation. With us as your regulatory partner your product is in good hands.

We provide full or shared regulatory responsibility in relation to:

Drug Development (Pre Approval)

• Scientific advice
• Regulatory strategy
• Clinical Trial applications
• DMF/ASMF or CEP Applications
• Marketing authorisation applications (NDA, ANDA, MRP, DCP, CP, NP)
• eCTD creation and publishing
• Dossier audits (gap analysis)
• Agency meetings (pre-submission / INDs)

Post-approval

• Annual Reports
• Variations
• Renewals
• PADER preparations and reporting
• Periodic Benefit-Risk Evaluation Reports (PBRER)
• Price and reimbursement applications

UK / European Region-Specific Regulatory support

• MA Holding and EU representation
• QP Services and Batch Release
• Translations & updates of product information
• Mock-up reviews
• Marketing (promotional) material reviews (IMA certified)