Regulatory & 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 strategic drug development services to emerging and mid-tier life science firms. With extensive pharmaceutical and biotechnology knowledge - with an average of over 15 years industry experience - members of our regulatory & 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:

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 your 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.

Clinipace Worldwide
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