Regulatory Strategy and Due Diligence
Ensuring Regulatory Compliance in Product Development.
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
