We establish virtual data rooms and tracking systems for the numerous project-associated controlled documents – including analytical protocols, reports, SOPs, specifications, certificates of analysis, tech transfer reports, master batch records for engineering and GMP runs, and stability protocols and reports. We also provide critical quality input and expert reviews into these documents as needed.

B4D has the experience to manage issues that inevitably arise along the way. We work with chemistry, manufacturing and analytical experts and quality consultants to oversee work conducted at CMOs. Our team provides cross-functional project management support using online collaboration tools for timelines and virtual meetings to keep on top of action items and minimize delays.

Initial supplier qualification can be based on self-assessments by the CMOs but we ensure that Quality agreements are established and site audits are performed prior to GMP manufacture.

Finding the right manufacturing contract manufacturing organization (CMO) for the project is key. The process starts with obtaining proposals from the most suitable CMOs based on experience and reputation – pricing is not the only consideration.

Early stage companies may not have the QA systems in place needed to meet GMP requirements. We work with you to develop a complete set of SOPs tailored to your company to ensure regulatory compliance as the project moves forward.