BioBoston Consulting Services helps biotech firms stay compliant with 21 CFR regulations, ensuring GMP, process validation, and risk management. Contact us for expert guidance!
In the tightly regulated environment of biotechnology, compliance with the U.S. Food and Drug Administration (FDA) is always mandatory. Biotech companies are also subject to one of the most stringent regulations, to the Code of Federal Regulation (CFR) – or more specifically 21 CFR which contains the requirements for producer, handler, and distributor for the pharmaceutical, biologic and device industries. This adherence ensures products are safe, effective, and of the highest quality.
Biotech firms turning to face these hurdles of 21 CFR can be highly daunting. This is where BioBoston Consulting Services comes into play, providing the necessary expertise to keep your company 21 CFR compliant.
What is 21 CFR and Why the Attention?
21 CFR refers to a portion of the U.S. Federal Code of Regulations that dictates FDA regulations for pharmaceuticals, biologics, and medical devices. It encompasses everything from Good Manufacturing Practices (GMP), laboratory tests, clinical trial requisites, to product and labeling. Regulations are intended to protect consumers and to make sure the products comply with strict safety, efficacy and quality standards.
For biotech, non-compliance can lead to recalls, litigation or a stoppage of production. Severe financial penalties, lawsuits, and damaged company reputation are all potential consequences of non-compliance.
How BioBoston Consulting Services makes sure you meet the 21 CFR
BioBoston Consulting Services is the helping hand for biotech startups to sort through the 21 CFR complexity. With expertise in FDA Guidelines, we provide consulting services that meet FDA regulations at every step of your development and production processes, products, and documentation. Here is how we can help:
21 CFR is divided into various parts, including 21 CFR Part 11 (electronic records and electronic signatures), 21 CFR Part 210/211 (GMP for drugs), and 21 CFR Part 820 (quality systems regulations for medical devices). BioBoston assists your business in understanding precisely what sections of 21 CFR apply to your operations and implementing practices to satisfy the requirements.
Good Manufacturing Practices (GMP) and Compliance
21 CFR is built upon one of its main components which is compliance with Good Manufacturing Practices (GMPs). Good Manufacturing Practices (GMP) regulations are the backbone of the pharmaceutical manufacturing industry, ensuring that products are consistently produced and controlled according to quality standards. BioBoston assists biopharmaceutical companies in establishing and maintaining GMP-compliant manufacturing processes, which encompasses the establishment of quality control systems, training of personnel, and validation procedures.
Documentation and Risk Management
21 CFR requires thorough documentation to ensure compliance at every step of the product development, from lab testing to clinical trials to manufacturing. Our experts at BioBoston guide you in ways to create and maintain accurate and complete records. We also help you avoid compliance issues by implementing risk management functions.
Validation and Verification
21 CFR mandates process validation for biotech firms. BioBoston supports you to validate production processes and perform the required verification tests ensuring all processes are regulatory compliant and help documenting the test results.
Training and Education
In order for everyone in your organization to understand the intricacies of 21 CFR compliance, BioBoston Consulting Services provides customized training to ensure your team is trained. We offer training in the areas of GMP, regulatory requirements, Pre-requisites, and compliance processes. We aim to empower your team to keep abreast of FDA regulations and avoid expensive errors.
Preparations for audit and inspection
The FDA performs routine audits to verify compliance with 21 CFR. Through internal audits and compliance review of your processes, BioBoston makes sure that your company is always audit ready and recommends improvements. We partner with your team to help you be ready for FDA inspections, ensuring you meet operational standards for compliance.
How BioBoston Consulting Services Can Help in Achieving 21 CFR Compliance?
Knowledge of 21 CFR Compliance: Our team has deep knowledge of the nuanced aspects of 21 CFR and their relevance for the biotechnology sector.
Personalized Approach: Every biotech firm is different, and we provide individualized solutions to address your specific needs.
Expert insight on regulatory and compliance expectations: The BioBoston team is well-versed in 21 CFR and other rules, so your company is always in compliance with the most recent expectations of the FDA.
Our services range from process validation and risk management to documentation and training, and everything in between, so you can always be sure your company stays compliant with 21 CFR.
Proven Track Record: BioBoston Consulting Services has a proven record of helping biotech companies the world over with 21 CFR compliance and regulatory success.
Welcome to BioBoston Consulting Services
If your biotech needs help with 21 CFR compliance, reach out to BioBoston Consulting Services. With seasoned experts at the helm, we provide practical solutions for ensuring your processes remain aligned with the FDA regulatory fabric, so you can deliver products that epitomize safety and quality excellence.
Our experienced consultants are familiar with the latest regulations and requirements related to 21 CFR, and we can work with you to develop a customized plan that fits your needs.
