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.



A GAP ASSESSMENT is a PROACTIVE approach which can provide an accurate picture for the management of the current quality management system. This type of audit can assist in formulating action plans prior to visits from Notified Bodies or Competent Authorities.

INTERNAL AUDITS are a REQUIREMENT for most ISO and Regulatory quality systems. Internal Audits are performed at least annually to internally identify potential compliance gaps. Internal Audits can also be used to assess the effectiveness of process interactions.

SUPPLIER AUDITS are a REQUIREMENT for most ISO based and Regulatory quality systems. Effectively managing the Supply Chain is crucial to ensure compliance in the Global Marketplace. Assessing and monitoring supplier capabilities and performance can help prevent unwanted surprises and regulatory compliance issues.

DUE DILIGENCE AUDITS are a must when considering a merger or acquisition. Before signing the agreement, ensure that the quality system and associated records are compliant with quality and regulatory requirements.


Biotech Research Group provides AUDITING with expertise with the following STANDARDS:

  • ISO 9001 Quality Management Systems – Requirements
  • ISO 13485 Medical devices – Quality Management Systems- Requirements for Regulatory Purposes
  • ISO 14001 – Environmental management systems – Requirements with guidance for use
  • ISO 14971 Medical devices – Application of Risk Management to Medical Devices
  • ISO 15378 Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • IATF 16949 Quality management system requirements for automotive production and relevant service parts organizations
  • Medical Device Single Audit Program (MDSAP)
  • ISO 17025 General Requirements for the Competence of Testing and Calibration Laboratories
  • ISO 22000 Food Safety Management Systems – Requirements for any Organization in the Food Chain
  • ISO 22442-1 Medical Devices Utilizing Animal Tissues and Their Derivatives – Application of Risk Management
  • ISO 22442-2 Medical Devices Utilizing Animal Tissues and Their Derivatives – Controls on Sourcing, Collection and Handling
  • ISO 22442-3 Medical Devices Utilizing Animal Tissues and Their Derivatives – Validation of the Elimination and/or Inactivation of Viruses and Transmissible Spongiform Encephalopathy (TSE) Agents
  • 21 CFR Part 4 Regulation of Combination Products
  • 21 CFR Part 11 Electronic Records; Electronic Signatures
  • 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
  • 21 CFR Part 110 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
  • 21 CFR Part 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
  • 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
  • 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
  • 21 CFR Part 801 Labeling
  • 21 CFR Part 803 Medical Device Reporting
  • 21 CFR Part 806 Medical Devices; Reports of Corrections and Removals
  • 21 CFR Part 820 Quality System Regulation
  • 21 CFR Part 1270 Human Tissue Intended for Transplantation
  • 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products
  • MDD 93/42/EEC Medical Device Directive
  • CMDR SOR/98-282 Canadian Medical Device Regulations
  • American Association of Tissue Banks (AATB) Standards for Tissue Banking


BRG provides CUSTOMIZED COURSES delivered to meet your training requirements available in the following topics:

  • Statistical Process Control
  • Design of Experiments (DOE)
  • Introduction to Quality Systems
  • Sampling Plans (Variable and Attribute)
  • Introduction to Process Validation
  • Documentation & Audit Preparation
  • FDA Inspection Readiness
  • Good Documentation Practices (GDP)
  • Good Manufacturing Practices (GMP)
  • ASQ Certification Preparation
  • Corrective and Preventive Actions (CAPA)
  • Quality System Requirements (QSR Overview)


Your company or facility can take advantage of consultation services covering the following areas of expertise:

  • FDA Consulting
  • Internal Audits
  • Supplier Audits
  • Gap Assessments
  • FDA 483 and Warning Letter responses
  • FDA 483 and Warning Letter remediation
  • Risk-based auditing systems (internal & supplier)
  • External regulatory and certification audit support
  • Document and Procedure Writing & Review
  • Process Optimization
  • Management Review
  • Regulatory Affairs support
  • Mock FDA Inspections
  • Design of Experiments (DOE)
  • Test Method Validations (TMV)
  • Corrective and Preventive Actions (CAPA)
  • Process Validations
  • Process Monitoring
  • Procedures and Work Instructions
  • Sampling Plans (Variable and Attribute)
  • Training

Click here to contact us about your project.