Regulatory Strategy

Pragmatic, Hands-On Support for Regulatory teams.

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.

Pharmaceutical Regulatory Strategy from Kinapse

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 guidance.
    (e.g. Labelling, local clinical trials, approval contingencies, climatic zones for stability studies and 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.

  • Paediatric development and PIPs.

  • New and revised health authority guidelines (e.g. ICH Q3D, Q12, QbD).

  • EU Directives for Medical Devices.

  • Serialization of commercial products as per new regulatory requirements.

  • Supply chain elements impacted by global changes.

For more information on our Regulatory Strategy services, get in touch.

Regulatory strategies for every Pharmaceutical market

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.

Source local regulatory experts with k-net

k-net is our network of Life Sciences experts, comprising of over 1,200 individual experts spanning 160 countries.

Using k-net, we can source local experts who can provide regulatory intelligence for any market, support local submissions and engage with local regulatory authorities on behalf of clients.

Learn more about k-net

Want to learn more?

Get in touch with our expert team
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Explore more of our services

Our Regulatory services are a real ‘power house’ within our portfolio. Working on a global scale we support the majority of the world’s Pharmaceutical companies helping them anticipate regulatory change and optimize their end-to-end regulatory activities.
View all of our services and see how they fit into the drug development life cycle.

Regulatory Maintenance

We have an unmatched global Regulatory Maintenance and operations capability to deliver exclusive end-to-end solutions for the life cycle maintenance of your product portfolio.