Maintenance obligations are to be met in all regulated fields

A wealth of expertise in clinical research exists within RegPak BioPharma Consulting.
We have extensive experience in the preparation, submission, and approval process for clinical trial applications in major clinical trial conducting countries.

Our team of experts is in regular agency contact and represents the cutting edge of clinical regulatory affairs. RegPak BioPharma Consulting can offer specialized consultancy advising on clinical and regulatory strategy for new product development, design of clinical trial protocols, and preparation of applications.

Our services include

  • Lifecycle maintenance

  • Dossier consolidation

  • MA duplication procedure

  • Pricing and reimbursement

  • Certificate of Pharmaceutical Product (CPP)