Services

We offer both dedicated and on-call regulatory affairs consulting services with client projects ranging from 3 months to 5 years. All consulting services are billed on a time and materials basis. The majority of Opus Regulatory consultants are permanent full-time employees (FTE) and average 14 years pharmaceutical industry experience, 10 years within RA.

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RA Functional Areas

 

Big Pharma

Having completed projects for over 200 pharmaceutical companies, we understand the demands associated with robust product pipelines, post-market compliance and corporate mergers. We recognize that large RA departments are unique, both organizational and culturally.

 

Development Stage to Mid-size Companies

For growing biopharmaceutical firms, we appreciate the vital need for senior regulatory specialists and generalists who are not afraid to "do it all". We recognize the compounded pressures of smaller companies to obtain product approvals while working with limited financial and human capital resources.