Compliance
1. Regulatory guidance
Biomanufacturing Solutions offers expert regulatory guidance to help biotech companies navigate the complex, ever-evolving landscape of compliance with key regulatory bodies, including Health Canada, EU MDR, and the FDA. Our team provides strategic consulting, helping you from the initial stages of development all the way to market approval. With an in-depth understanding of global regulatory frameworks, we make sure your product meets all safety, legal, and quality standards. From initial consultation to final approval, and from documentation preparation to regulatory submission and audits, we streamline the entire process, reducing both the time and costs needed to confirm market readiness. Look no further for a trusted guide who prioritizes precision and care. Click here to download our “Supplier Self-Assessment Questionnaire”.
2. Qualification
Our qualification and compliance services confirm that your biomanufacturing operations meet critical regulatory standards such as GLP, GMP, and ISO 9001. Biomanufacturing Solutions performs comprehensive evaluations of your equipment, processes, and facilities to guarantee that everything is functioning within the required compliance parameters. We offer validation protocols, gap analyses, and corrective action plans that address areas of risk or non-compliance. Our proactive approach helps mitigate potential regulatory issues, all while strengthening the integrity of your biomanufacturing processes—helping you stay aligned with both national and international standards, and paving the way for a seamless path to market. We take pride in seeing your product development run smoothly.
3. Regulatory compliance
Navigating the complex regulatory frameworks of agencies such as Health Canada, the FDA, and EU MDR can be overwhelming for biotech companies. Biomanufacturing Solutions offers comprehensive support to guarantee full regulatory compliance, providing expert guidance in documentation preparation, regulatory submissions, and audits. Our deep understanding of regional and global regulations helps your product meet all necessary standards for market approval. We manage all aspects of communication with these authorities—streamlining the approval process and reducing the risk of regulatory setbacks, with the aim of helping your product enter the market as confidently and efficiently as possible.
4. Accreditations
Biomanufacturing Solutions provides expert assistance in obtaining critical accreditations, including FACT (Foundation for the Accreditation of Cellular Therapy) and AABB (American Association of Blood Banks). These certifications are essential for companies engaged in cellular therapy, blood banking, and related sectors. Our team confirms your processes align with the rigorous standards set forth by these accrediting bodies, providing the operational and compliance support necessary to meet their high requirements. Achieving these accreditations bolsters your credibility in the biotech space and positions your company for long-term success in a highly regulated environment.
5. ISO certifications
Achieving and maintaining ISO certifications such as ISO 9001 and ISO 13458 play an essential role in biomanufacturing quality management processes. Biomanufacturing Solutions specializes in helping companies implement and sustain these certification frameworks. Our services cover everything from internal audits and risk assessments, to process evaluations and continuous improvement strategies. We make sure your operations adhere to the highest standards of quality and compliance, resulting in a true culture of excellence. With our support, you can maintain your ISO certifications and elevate your reputation of excellence in biotech.
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