The CRO Group is a consulting service provider to regulated industries including biotechnology, medical device, and IVD manufacturers in product approvals, quality systems, part 11, risk management, and clinical studies..
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The CRO Group conducts internal audits, supplier audits, mock inspections and audits, and risk management audits on behalf of regulated industries.
We conduct due diligence audits for both pre-acquisition as well as VC/Angel assessments of potential investments.
We perform information technology audits according to GAMP4, Part 11 and clinical investigation data requirements.
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CRO Group training programs for regulated industries run the spectrum from a one or two hour seminar on a specific requirement to one or two days on the entire EU Medical Device or IVD Directive, the FDA Part 11 (21 CFR 11) Regulation, and or establishing an Internal Audit program addressing ISO 13485:2003 and QSR, Canadian Medical Device Regulation, and EU MDD
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