QUALITY AND REGULATORY
BioProcess Technology Consultants provides guidance and support for all aspects of CMC related quality and regulatory affairs. Today’s demanding regulatory environment requires solutions that maintain high quality, without draining valuable resources. Our expert consultants can support or supplement your internal quality resources and deliver solutions that accelerate your product development from clone to commercial®.
Quality
- Quality Assurance Support
Our quality experts can assist your quality assurance staff by preparing or reviewing SOPs, documents and approving specifications, analytical methods, or process qualifications. For clients who do not have an internal Quality Assurance department, we can fulfill this roll to help you comply with all regulatory requirements appropriate to the stage of your product development and to insure appropriate product quality.
- Quality Systems Evaluation and Audits
BioProcess Technology Consultants has extensive experience in conducting audits of raw material suppliers, contract manufacturers, and testing laboratories. Using our proprietary Audit Check List, we quickly and efficiently cover all aspects of cGMP compliance at an audit site. We provide detailed audit reports and observations to facilitate maintaining compliance at the contractor or vendor and to provide complete documentation of all actions taken.
For clients considering the use of contract service providers, we can review the contractor’s quality systems and documentation, validation, and overall state of compliance, and also evaluate the appropriateness of the contractor’s facilities for your project. Our experts will work with you or your service provider to ensure that any outstanding issues are addressed prior to manufacture or testing of your product.
- Quality Agreement
A Quality Agreement describes the mutual responsibilities of both the service provider and sponsor during all aspects of manufacture or testing of your product. A good Quality Agreement will minimize surprises, facilitate smooth and efficient communication between the sponsor and contractor, and protect both parties. BioProcess Technology Consultants can write, review and/or negotiate Quality Agreements to ensure that they are comprehensive and protective, yet appropriate for the stage of development of your product.
- Training
We provide advanced training on such topics as quality and regulatory requirements throughout development, GMP compliance, and pre-approval inspection readiness. We also routinely teach a variety of in-house training and educational seminars on all aspects of fermentation, cell culture, and downstream processing, including media development, strain selection, protein purification, scale-up, validation, and manufacturing. Our seminar and training programs vary from one-hour lectures on specific topics to multi-day training programs that allow you to leverage our expertise across your organization and impart your employees with the critical skills and insights necessary to perform their jobs.
- Quality System Design
For small start-up or virtual companies, designing and implementing quality systems is an important, but resource intensive activity. Our experts will design a quality system that meets both regulatory expectations and the development stage of a company’s products. A complete quality system will include the documents and procedures necessary to establish a quality unit at your company and define corporate quality policies, as well as SOPs, batch records, and testing protocols that provide for accurate and consistent recording of primary data and fulfill all cGMP requirements. We design and help you implement quality systems that provide for adequate flexibility appropriate for the stage of your product development but also provide a solid foundation for use in later stages. By ensuring that quality considerations are included in early stage decisions, we help facilitate the rapid development of robust and acceptable products and processes.
Regulatory
- CMC Submissions
We plan, manage, review, and author CMC information for regulatory filings. We have supported development and commercial submissions in US, Canada and Europe.
- CMC Regulatory Issues
We assist with regulatory interfaces, meetings, and responses to regulatory requests from pre-IND to pre-approval inspections (PAI) and post-approval changes. We perform internal/external audits, mock-audits, and pre-approval readiness evaluations and assistance.
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