Regulatory Trials

Therapeutic Area Experience
Focus on NIS
Regulatory Trials
e-CRF
QA Activities
Medical Writing
Phv in Clinical Trials

GB Pharma Group is also able to support in the regulatory submission and conduction of:

  • PASS (Post-Authorization Safety Studies)
  • PAES (Post-Authorization Efficacy Studies)

Moreover we have experience in the preparation and regulatory submission and the conduction of:

  • PIP (Pediatric Investigational Plans) or PIP waivers: meeting and submission to PDCO
  • ORPHAN DRUGS: submission/designation to COMP and following clinical development plan
  • Preparation of Clinical Development Plan

The rigorous approach to the trial conduction together with the experience to the global IMP development, helps to focus on the goal of SPEEDING THE TIME TO MARKET.