We provide a focused approach to the pharmaceutical clinical development of drugs, devices biologics for regulatory submissions.

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GxP (GMP, GCP, GLP) & Regulatory Consultancy
We provide rapid, comprehensive effective advice to clients on a broad range of regulatory & technical issues

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Experience with all phases of product development.
Pre-clinical, clinical CMC, CRO oversight, regulatory interactions, document preparation, review & filings.

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We are a comprehensive consortium of experienced clinicians, pharmaceutical scientists, regulatory strategists & business development experts who provide product & business development assistance & solutions for the pharmaceutical, biotech, medical device industries.



Services

We have an extensive experience with all phases of product development, including pre-clinical, clinical (Phase I-IV), CMC (analysis, formulations, process, production), outsourcing, CRO oversight & regulatory interactions, document preparation, review & filings. Learn more

About Us

From project conception to product launch, we provide a focused approach to the pharmaceutical & clinical development of drugs, devices & biologics for regulatory submissions. Learn more

Product Development

We are involved in the development & approval of novel drug, device & biologic therapies with strategic partners. For further information regarding strategic business development opportunities. Learn more


A great one passed on today, Prof. Sandford Bolton. Thank you for a life of giving to others. We love and miss you.
108 days ago

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