Regulatory Strategies

Regulatory Strategies

Regulatory Strategies

Our Regulatory Strategy team have the deep capabilities required to complement your in-house team and deliver strategies to support the successful commercialization of product portfolios.

We regularly help clients develop and implement strategies for the following activities:

  • Global Regulatory Lead support.
  • Content definition and submission strategy.
  • Regulatory Affairs and CMC strategic.
    (e.g. Labelling, local clinical trials, approval contingencies, local requirements for document types, samples, quality control and launch.)
  • Scientific advice and interactions with regulatory authorities.
  • Submission gap analysis.
  • Mergers & acquisitions and related regulatory issues.
  • New and revised health authority guidelines (e.g. ICH Q3D, Q12, QbD).
  • Serialization of commercial products as per new regulatory requirements.
  • Supply chain elements impacted by global changes.

Regulatory strategies 

We can help with your regulatory strategy, no matter what markets you work in.

We have a network of local affiliates and agents, who can provide local submission support and case management in any Pharmaceutical market. We have worked closely with these experts over many years – they allow our clients to flexibly approach any market and confidently comply with regulations.

The one stop solution for Regulatory Operations

Our expert Regulatory Operations team are well equipped with exclusive and state-of-the-art technology. We’re capable of tracking, executing and managing the regulatory operations activities of all submission types for our clients.

We help our clients with:

  • Document Publishing, including all submission types and formats.
  • Submission Publishing, including paper, NeeS
  • Submission Dispatch Management including electronic gateways, CDs and Prints.
  • Product dossier and document management.
  • Regulatory Information Management (RIM)- strategy development, process and systems diagnostics, system configuration and associated business process alignment.
  • Labelling operational support.