Biotech Research Group is a diverse group of QA Consultants assisting clients to develop quality assurance programs from scratch. Regardless what industry you are in pharmaceutical, medical devices, cosmetics, or biologics / biotechnology, the FDA requires a robust quality management system. The method by which a company achieves and maintains FDA compliance is different for each company. Our quality assurance consultants can be utilized to work side by side your quality assurance team or can be hired to outsource your entire quality and compliance department. Clients find outsourcing their quality and compliance department is affordable and saves on tedious employee training due to growth or turnovers.

Our services include:

  • SOP implementation
  • SOP training
  • Employee training programs
  • Mock FDA inspections
  • Vendor audits
  • Facility audits
  • FDA 483 Observations
  • FDA warning letters
  • Validations
  • Clean room cleaning and operation procedures
  • Environmental monitoring
  • Recalls
  • Adverse reactions
  • Deviations and corrective action/ preventive action plans
  • Logistical exportation of products
  • FDA compliance
  • Quality system regulations

Our QA Consultants understand that the quality management system is the foundation for safe products and happy consumers. Biotech Research Group can craft a quality management system and tailor it to your needs. No project is too little or too big.

Click here to contact us about your project.