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.