Regulatory and Strategic Development

Supporting the Strategic Development of your Product

As a global digital contract research organization (CRO), we specialize in providing a full complement of regulatory and strategic development services to emerging and mid-tier life science firms. With extensive pharmaceutical and biotechnology knowledge – with an average of more than 15 years industry experience – members of our regulatory and strategic development (RSD) team provide expert advice covering regulatory, non-clinical, clinical, manufacturing, product registration, and post-marketing support. In addition, our in-house publishing group can prepare electronic or paper dossiers for worldwide regulatory submission.

We also offer clients services in the following practice areas:

  • Global Regulatory Affairs
  • Clinical Trial Applications and Product Registrations
  • Legal Representation
  • Regulatory Publishing
  • GxP Auditing and Quality Assurance
  • Chemistry, Manufacturing, and Control (CMC)
  • Medical, Scientific, and Technical Writing
  • Due Diligence for Mergers, Acquisitions, and Financing

With vast experience working with competent regulatory authorities around the world, we regularly represent our clients in meetings with these agencies – and can also act as their legal agent. Frequent, direct interaction with regulatory authorities puts us in a strong position when preparing and submitting investigational new drug applications (INDs) and marketing applications for pharmaceuticals and biotechnology products.

Additionally, we provide post-marketing regulatory support, such as changes to approved labeling, line extensions, manufacturing changes, label and promotional materials review, and license renewals.

Looking for Regulatory and Strategic Development Help?

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