Clinipace, Inc.

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Description

We provide expert Quality Assurance consulting services to pharmaceutical, biotechnology, medical device, and dietary supplement companies to help ensure they are in compliance with current business practices and regulations. Our team of auditors can perform a detailed assessment of your existing quality systems and processes, to highlight problem areas and recommend improvements, so that you can build quality systems that are appropriate for your company’s stage of development. We can assist you with all aspects of compliance, as they impact your product, including GLP, GMP, QSR, and GCP.

For medical devices, good engineering does not necessarily guarantee clinical or commercial success. At times, regulators and device manufacturers seem to be on opposing sides of the playing field. Regulators often contend with pressure to fast-track approvals while at the same time ensuring product safety and efficacy. On the other hand, manufacturers risk spending time and resources to develop a device, only to not receive approval to go to market.

Welcome to the team, Dr. Roger Morgan! Dr. Morgan, MD, FACS, recently joined Clinipace as Executive Vice President of Global Medical Affairs; bringing over 25 years of experience in the healthcare and clinical research fields.

Clinipace Worldwide offers you a team of multi-national Regulatory Affairs professionals who have vast experience working with competent regulatory authorities around the world.

I don’t think clients realize how closely functional groups (i.e. Clinical, Data Management, Programming, etc.) work together to ensure we provide the best level of service possible.

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