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Product Development Done with Quality & Expertise

Strong Foundation - Successful Results

Biotech Research Group is a full service regulatory and product development consulting firm. BRG has an excellent reputation as a leading regulatory and scientific affairs consulting firm, which has clients and consultants in over 60 countries across the globe. The primary aim of BRG is to provide efficient and expeditious services andgive the best solutions for our clients’ products that include pharmaceutical consulting, medical devices, healthcare information technology, and scientific services. In addition, BRG is an experienced and knowledgeable biologics consulting group.

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KEYS TO SUCCESS

Quality

Quality

Biotech Research Group carefully designs and executes clinical research and product development plans with expert quality management. BRG is a leader in FDA regulations and compliance.

Global Experts

Global Experts

Biotech Research Group has experts in over 60 countries with diverse therapeutic expertise. BRG offers one stop shopping to include toxicology, pharmacokinetics, statistics, epidemiology and pharmacovigilance just to name a few.

Cost & Time Effective

Cost & Time Effective

Biotech Research Group's streamline processes are efficient and expeditious. Each product development or clinical research plan is tailored to meet the client's budget and timeline. Our plans include services in pharmacovigilance, clinical trials, litigation expertise, and regulatory affairs.

Areas of Expertise

Biologics

Biologics

BRG can help with all FDA CBER requirements such asBLA, Tissue Establishment Registrations, blood and tissue products, vaccines, allergenics, cellular & gene therapy products.

Medical Devices

Medical Devices

Getting your medical device FDA approved is vital, so let the BRG experts help with your PMN, PMA, and 510k applications. We have experience in implants & prosthetics, surgical, cosmetic, and general hospital devices.

Drugs

Drugs

BRG provides services for pharmacovigilance, ANDA, NDA, OTC, drug labels, IND and Pre-IND. Regardless of your need, BRG can offer fast and efficientpharmaceutical consultingservices.

Quality Assurance

Quality Assurance

Biotech Research Group can serve as your QA department or offer assistance when you need it most. We offer services in ISO clean room operation & maintenance, audits, SOP implementation & training, hazard control plans, environmental monitoring, FDA adverse reporting events, deviations and corrective actions.

Specialty Services

Specialty Services

Biotech Research Group provides a wide variety of drug consulting specialty services that will help you reach the market faster. Our regulatory consulting firm has designed many additional services to help our clients succeed with regulatory compliance. From pharmacovigilance to literature searches, our regulatory affairs professionals can help. Biotech Research Group is a full-service consulting firm offering services to meet all client needs.

Legal Support

Legal Support

Biotech Research Group provides support to the legal community for qualifying cases. Our FDA experts are knowledgeable in the pharmaceutical, medical device and biotech industries. Our reputation and integrity has earned trust in the courtroom due to our meticulously prepared scientific research, reports, and testimony. Our team has worked with some of the largest legal firms in the nation. Biotech Research Group has participated and is qualified to give their expertise on single cases, multi-district litigations and class action law suits.

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