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SMALL TO LARGE PROJECTS- BIOTECH RESEARCH GROUP CAN HELP

Biotech Research Group is one of the leading data-focused clinical scientific organizations in the USA, which offers consulting in medical devices, IND, Pre-IND, quality assurance, FDA dietary supplements, scientific writing, and innovative solutions to the customers across the globe. With the extensive knowledge in FDA approvals and clearances, the scientists and regulatory affairs professionals at BRG is ideal for helping clients with their product needs. Biotech Research Group are experts for FDA approval in 510k, ANDA, NDA, and product labeling. BRG’s mission is to provide high-quality consulting for FDA regulated products, together with exceptional customer service around the globe. Biotech Research Group can assist clients with their pre IND FDA meeting.

What do we do?

Biotech Research Group conducts scientific and regulatory affairs consulting, such as IND consulting, 510k consulting and NDA consulting. We adhere to the best international practice in scientific research, drug development, medical writing, and regulatory services.

Core Services

Scientific Research

Scientific Research

Biotech Research Group is a global research organization providing scientific research. BRG offers extensive literature reviews, toxicology, medical & scientific writing, new drug investigations and applications. BRG offers FDA establishment registration and annual renewals.

Product Development

Product Development

Our highly qualified and experienced RAPS consultants create a strategic plan to have your product approved by the FDA and can help with FDA compliance. Biotech Research Group provides services for USFDA ANDA, NDA regulatory services (505b2), 510k, IND, Pre-IND, OTC and other FDA applications.

Quality Assurance

Quality Assurance

BRG offers quality assurance services such as SOP implementation, training and maintenance, quality control audits, validation services, corrective action plans, hazardous plans, communication plans, deviations including product deviations, adverse reactions and complaints, environmental monitoring, and employee training programs. BRG can serve as your QA department or BRG can work side by side with your QA department to ensure local, state and federal regulations are being adhered.

CONSULTING SERVICES

Clinical Trials

Clinical Trials

Biotech Research Group will partner and guide your company through all phases of your clinical trials. From Phase I to Phase IV, BRG will tailor a project plan for your needs. Choose a partner that is right for you and has the know-how to accomplish your goals.

Quality Assurance & Quality Control

Quality Assurance & Quality Control

Quality control plays an intricate role in all clinical trials. BRG offers a stand-alone service for independent quality control inspections for sites. BRG performs vendor audits, implementation/ review of validation protocols, and standard operating procedures management and implementation. BRG experts are knowledgeable with cGMP, cGTP, and GCP. Environmental monitoring, CAPA monitoring, and ISO Clean Room Maintenance services are available.

Scientific & Medical Writings

Scientific & Medical Writings

BRG offers professional writing services for package inserts, clinical synopsis, editorials, product literature, research papers, Patient Information Sheet, questionnaires, Interim and Final Clinical Study Reports, Periodic Safety Update Reports, and Adverse Reaction Reports.

FDA Services

Compilations/ Submissions/ Interactions

Compilations/ Submissions/ Interactions

  • Pre-IND/ IND
  • NDA/ ANDA
  • 513g
  • 510k
  • 505(b)(2)
  • BLA
  • PMA/ PMN

Nonprescription Drugs

Nonprescription Drugs

  • Establishment Registrations
  • Product Listings
  • Citizen Petitions
  • Drug Facts Labeling
  • Formulation Changes
  • Rx-to-OTC NDAs

FDA Essentials

FDA Essentials

  • Post-approval Drug Safety Surveillance
  • 483s
  • Warning Letters
  • PSURs/ PADERs
  • Product Deviation Reporting
  • Annual Reporting