The regulatory approval process can be daunting for even the most seasoned team and well-planned project. With great reason, regulatory authorities are placing value in clinical trials that have comprehensive safety infrastructures. Chiltern’s Strategic Regulatory team is your end-to-end solution for navigating regulatory processes throughout your product’s life cycle.

Our team uses a collaborative approach to generate a personalized strategy that aligns with your business goals and gives you the best chance of regulatory approval.

Whether you are a large company or a small one, we provide guidance through all stages of your product’s journey. Our goal is to mitigate risk and respond to any crisis quickly so you avoid the headaches associated with non-compliance. Our team of regulatory investigators and quality professionals are problem solvers and well-versed in biopharmaceutical, medical device and diagnostic regulations.

You can focus on bringing new treatments to patients when you trust our Strategic Regulatory team to navigate the ever-changing regulatory environment for you.

Strategic Regulatory Services

  • Clinical trial authorizations (CTA)
  • Competent authority meetings
  • Due diligence
  • IND/IDE/BLA applications
  • Local representative
  • Pediatric investigation plans (PIP)
  • Product labeling
  • Regulatory consultancy
  • Reimbursement
  • Safety risk minimization plans
  • Scientific advice, protocol assistance
  • Suitability for registration