Our Story


Welcome to The CRO Group

The CRO Group is a leading global consulting organization and service provider .We specialize in Medical Device, Biotechnology, In-Vitro Diagnostic, Over The Counter (OTC), Software as a Medical Device (SaMD), and mHealth product companies seeking FDA Approval, CE Marking, Clinical Studies, Quality, Risk, as well as other Regulatory Management services. We are also registered with FDA as a U.S. Agent, and in Europe as an Authorised Representative. We value our clients and provide worldwide services.

CRO stands for “Contract Regulatory Organization.” We are a consulting organization with clients in 3 dynamic industries. We work with regulated industries including the developers and manufacturers of medical devices, In Vitro Diagnostics (IVDs), and biotechnology including genetic IVDs and collagen and human based materials. We also provide auditing, management and training services for Notified Bodies and Registrars. We also provide an array of consulting services for software developers and manufacturers with applications targeted at the regulated industries as well as regulatory agencies.

Our specialties include cost effective CE Marking and Quality System / ISO 13485/CMDCAS certification and registration programs, and FDA QSr (Quality System regulation) compliance programs, including the new Design Control Requirements. We also prepare a variety of submissions including 510(k)s, 513(g)s, technical files, PMAs, design dossiers, Canadian license applications, clinical study protocols, and IDEs.

With partners and consultants in the USA, Canada and Europe, The CRO Group is uniquely qualified to handle virtually all your regulatory compliance and market access issues. Each partner and affiliate is qualified to handle general medical device and quality system issues such as labeling, risk management, and design and process validations. Then, for subspecialties such as clinical investigations, sterilization validations, dielectric withstand, or waste disposal, we rely on our partners and affiliates robust backgrounds with medical and pharmaceutical product manufacturers. And by the way, we also provide “CRO” – contract research organization – related services for our clients, including clinical study design, protocol development, IRB/IEC approval submissions, clinical trial management and auditing, and preparation of reports to support submissions.

ABOUT OUR CLIENTS:

The CRO Group works with companies large and small, with as few as two employees, and with multiple divisions and staffs in the thousands. Most of our clients are smaller in size, need high quality regulatory services, but found it impossible to afford a salaried regulatory professional. Nevertheless, large, multidivision corporations have used one or more CRO Group partners for specific projects or tasks. Even in the large company, it may make business sense to rely on the expertise of The CRO Group partners to supplement fully loaded resources in “worker-bee”, leader, or manager mode. We protect our client’s privacy by not publicizing clients with contracts in progress. All of our clients permit us to list their names as references if they were satisfied with the quality of our services, at the conclusion of the contract.