Regulatory Affairs (Global)

At PM Life Sciences, our Regulatory Affairs offering provides end-to-end strategic and operational support across the full product lifecycle, ensuring that scientific innovation is translated into globally approvable, compliant, and commercially viable products.

Led by senior regulatory leadership with over 25 years of global experience, we support pharmaceutical and biotechnology companies across small molecules, biologics, vaccines, advanced therapies and complex products, delivering tailored regulatory strategies aligned with development, manufacturing and commercial objectives.

Strategic Regulatory Leadership

We provide senior-level regulatory leadership and guidance from early development through to post-approval lifecycle management, including:

  • Global regulatory strategy development (EU, US, UK, Canada, MENA, APAC)

  • Regulatory pathway optimisation (IND, IMPD, CTA, NDA, BLA, MAA)

  • Scientific Advice, Pre-IND, and Health Authority interactions

  • Orphan Drug Designation (ODD), PIPs, and expedited pathways (e.g. ILAP, Fast Track)

  • Regulatory risk assessment, mitigation, and approval readiness

Our approach ensures that regulatory strategy is fully aligned with clinical development, CMC strategy, and commercial goals, enabling efficient and predictable product progression.

CMC Regulatory Excellence (Module 3 Leadership)

We offer deep expertise in Regulatory CMC strategy, authoring, and governance, including:

  • Full ownership and delivery of CTD Module 3 (drug substance and drug product)

  • Authoring and review of CMC documentation across IND/IMPD, NDA/BLA, and MAA submissions

  • Development and implementation of control strategies (CQAs, CPPs, specifications)

  • CMC gap analyses and regulatory readiness assessments

  • Lifecycle management including variations, renewals, and post-approval commitments

We ensure that regulatory documentation remains fully aligned with manufacturing processes, analytical methods, and quality systems, supporting inspection readiness and long-term compliance.

Development to Commercial Lifecycle Integration

We support seamless progression from early development through to commercialisation, including:

  • IND/IMPD-enabling strategies and early-phase regulatory positioning

  • Transition from clinical to commercial manufacturing (scale-up, validation, tech transfer)

  • Management of post-approval lifecycle activities, including global variations and worksharing procedures

  • Global expansion strategies and multi-region submissions

Our integrated approach ensures continuity between development data, regulatory submissions, and commercial supply chains.

Health Authority Interface & Inspection Readiness

We act as a trusted regulatory interface with global Health Authorities, including:

  • FDA, EMA/CHMP, MHRA, Health Canada, WHO and emerging markets

  • Preparation and leadership of regulatory meetings and scientific advice

  • Coordination and authoring of responses to regulatory questions

  • Inspection readiness, audit support, and remediation activities

We bring extensive experience operating in high-risk, inspection-facing environments, ensuring confidence in both submissions and regulatory interactions.

Regulatory Data, Governance & Compliance

We support modern regulatory requirements through:

  • Governance of regulatory content and data across systems (e.g. eCTD, Veeva, QMS)

  • Alignment with ICH guidelines (M4Q, Q8–Q12, Q14 and beyond)

  • Ensuring traceability and data integrity in line with ALCOA+ principles

  • Support for evolving regulatory frameworks, including structured content and digital submissions

This ensures that regulatory information is consistent, traceable, and inspection-ready across the lifecycle.

Partnering for Success

As a regulatory partner, we operate at the intersection of science, manufacturing, and regulatory strategy, ensuring that development programmes are not only compliant, but efficient, scalable, and commercially viable.

We work collaboratively with internal teams, CDMOs, CROs, and external partners to deliver practical, high-quality regulatory solutions, supporting successful approvals and sustained product performance in global markets.