FDA compliance, GMP, clinical research, and laboratory regulatory requirements for Massachusetts biotech companies.
Massachusetts is the global epicenter of biotechnology, with the highest concentration of biotech companies in the world. The Kendall Square area of Cambridge alone hosts over 150 biotech companies. The state leads in drug discovery, medical devices, and genomics research. Biotech companies must navigate complex FDA regulations, clinical research requirements, and laboratory safety standards while maintaining data security compliance.
All companies in Massachusetts, including those in the biotechnology & pharmaceuticals sector, must comply with Massachusetts data security and privacy regulations:
Pro Tip: Start with 201 CMR 17.00 - Massachusetts' foundational data security regulation that applies to all businesses handling personal information of Massachusetts residents.
These frameworks are legally required for biotechnology & pharmaceuticals companies. Non-compliance can result in significant penalties, fines, and legal consequences.
Standards for the Protection of Personal Information of Residents of the Commonwealth
Massachusetts comprehensive data security regulation requiring businesses to protect personal information of Massachusetts residents.
Massachusetts General Law Chapter 93H - Notification of Security Breaches
Massachusetts law requiring notification of security breaches involving personal information.
Title 21 Code of Federal Regulations Part 11 - Electronic Records; Electronic Signatures
FDA regulation establishing criteria for trustworthy electronic records and signatures in FDA-regulated industries, making them legally equivalent to paper records and handwritten signatures.
FDA Current Good Manufacturing Practice for Finished Pharmaceuticals (21 CFR Parts 210 and 211)
The FDA Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211) establish minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of drug products. All pharmaceutical manufacturers, including Massachusetts biotech and pharmaceutical companies, must follow CGMP to ensure products meet quality, identity, strength, and purity requirements. Massachusetts is home to over 500 life sciences companies, many subject to these regulations. Violations can result in Warning Letters, Consent Decrees, product seizures, injunctions, and criminal prosecution with fines up to $250,000 per individual/$1 million per company and up to 10 years imprisonment for knowing violations.
While not legally mandatory, these frameworks represent industry best practices for biotechnology & pharmaceuticals companies. Implementing these can improve security posture, build customer trust, and provide competitive advantages.
National Institute of Standards and Technology Cybersecurity Framework Version 2.0
Voluntary framework providing guidance for organizations to manage and reduce cybersecurity risk through a common language and systematic approach.
Information security, cybersecurity and privacy protection — Information security management systems — Requirements
International standard specifying requirements for establishing, implementing, maintaining and continually improving an Information Security Management System (ISMS), with risk-based approach to protecting information assets.
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
Federal biosafety guidelines establishing institutional oversight requirements for research involving recombinant or synthetic nucleic acid molecules. Requires Institutional Biosafety Committees (IBCs) and biosafety level containment based on risk.
Additional frameworks that may apply depending on your specific business operations, client requirements, or industry partnerships.
Follow this recommended sequence to achieve compliance as a Massachusetts biotechnology & pharmaceuticals company.
Begin with 201 CMR 17.00 (data security) and M.G.L. c. 93H (breach notification). These apply to all Massachusetts businesses and form the foundation of your compliance program. Prepare for MDPA compliance (effective 2025).
Address all mandatory frameworks for the biotechnology & pharmaceuticals sector. These are non-negotiable legal requirements with enforcement and penalties.
Strengthen your security posture with recommended frameworks. While not mandatory, these can differentiate your company, win customer trust, and may become requirements for certain contracts or partnerships.
Compliance is not a one-time project. Maintain ongoing monitoring, conduct regular assessments, update policies as regulations change, and train employees continuously. Use MyRHC to track your compliance status and stay informed of regulatory updates.
Get started with MyRHCMyRHC provides comprehensive tools and guidance for Massachusetts biotechnology & pharmaceuticals companies to navigate complex compliance requirements.