Effective Regulatory Strategy and Due Diligence

Effective Regulatory Strategy and Due Diligence

By adopting a strategic approach, following regulations, and optimizing your product development content, you can achieve on-time registration and commercial launch of your product. Our team has extensive expertise in regulatory strategy, including local administrative requirements, CMC, pre-clinical and clinical data/module reviews, gap assessment, and effective remediation. We provide valuable support to identify and address development pitfalls, facilitating a smoother registration process for you.

Our offering includes:

  • Accelerated assessments
  • Breakthrough Therapy Designation Requests
  • Repurposed medicinal products
  • USFDA Accelerated approval and EU Prime designation request
  • Orphan drug status designation
  • Paediatric Investigation Plan (PIP) / Initial Paediatric Study Plan (iPSP)
  • Due diligence assessments
  • Regulatory Strategy Plans

Helping You Execute All Strategic Steps

  • We have years of experience in regulatory strategy and due diligence for a wide range of products, with extensive knowledge of regulations.
  • Our team employs a multidisciplinary approach, offering strategic guidance and compliance support throughout all development phases.
  • Our excellence is driven by meticulously reviewing and assessing existing documentation, ensuring adequacy and alignment of regulatory requirements.
PLG has always demonstrated consistent delivery and a good ability to offer qualified consultants adapted to our needs.

Head of Pharmacovigilance and Medical Information

Head of Pharmacovigilance and Medical Information