Regulatory guidance to help you navigate each step of the approval process.

At CCPS, our Regulatory Affairs consulting team are experts at bringing products and compounds to market, navigating ever-changing global regulations and guidelines. With our finger firmly on the pulse of change, CCPS helps shape your roadmap to commercial success.
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Where do you want to go and what are your critical drivers?

CCPS will determine the best path to get you to your destination saving you time and minimizing costs.

Regulatory Strategy

CCPS supports and enhances the complete product development cycle from R&D and POC through post-approval marketing by combining our regulatory knowledge with an understanding of business and industry practices.

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Clinical Trial Design

CCPS helps navigate the clinical trial process by leveraging our years of experience supporting the world’s leading pharmaceutical, biotechnology, medical device, National Institutes of Health,  and other federal agencies.

Compliance Solutions

CCPS assists with the continuous compliance challenges by providing strategic input and operational support into Variation Application, Renewal Applications, Transfer of ownership applications, and readability assessments.

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Marketing Authorizations

CCPS offers expertise in the development, review, evaluation and preparation of scientific information modules for regulatory submissions.

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Scientific Communications

CCPS provides communications support ranging from providing analysis guidance for scientific advisors to conducting analyses and writing manuscripts.

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Regulatory Outsourcing

CCPS works as an extension of your in-house resources to reach the point of approval quickly and reliably by leveraging our experienced Regulatory Affairs team.

what is the ccps difference

CCPS understands there are numerous providers of regulatory services, and we do not want to just be another vendor on your list. Our modular-based approach to consulting brings you the support you need – when and how you need it. Designed to be your strategic GPS, CCPS offers support for all your regulatory consulting needs.

Our experienced Regulatory Affairs consulting team has roots in treatment development for chronic, acute and life-limiting conditions, rare disease and orphan drug development. We have the skills and experience to design, launch and manage programs worldwide – managing every aspect of each unique program from conception to close out.

CCPS offers a feasibility assessment to better understand your specific regulatory requirements helping us to design a program roadmap ensuring compliance and commercial success.

Contact us to experience the CCPS difference today.