Regulatory Affairs Services
A Comprehensive Suite of Services Covering All Aspects of Regulatory Affairs Requirements
The Key to Regulatory Success
PLG offers a comprehensive global regulatory affairs service with decades of expertise in drug, biologics, and regenerative product submission. Our regulatory experts provide strategic guidance, project management, and regulatory reports to help clients navigate the investigational submission process (IND, IMPD, CTA) and marketing applications (NDA/ANDA, MAA) in key markets worldwide. With support from our global network of consultants and partners, we provide regulatory strategy development, operational support, dossier preparation, and execution for a seamless regulatory journey. Our goal is to minimize regulatory risks and identify the best way for product development, registration, and market access.
Our services
Regulatory Agency Representation
Regulatory Strategy and Due Diligence
Preparation and Management of Regulatory Submission
Your trusted partner in regulatory affairs
- With thousands of projects delivered, our experts combine their experience in regulatory operations, agency management, and a deep understanding of processes to manage regulatory operations effectively.
- We have led and assisted clients in all regulatory procedures from Clinical Trials (IND/IMPD/CTA), Marketing Authorisation (BLA, NDA, MAA) applications, scientific advice, and all pre- and post-approval licenses.
- Our worldwide team comprises regulatory experts, medical writers, and consultants, ensuring a multidisciplinary approach every step of the way.
- As we adapt to new trends, our experts offer support in a wide spectrum from small to complex molecules, gene therapy, biologics, and beyond.
PLG offers a deep expertise on European regulatory environment while showing top tier service quality, especially concerning responsiveness and flexibility.
Head Development Quality Assurance & QP
