Consulting Solutions
BioConvergence is committed to addressing each client's unique requirements. Though we list below our expertise in Engineering, Validation, Operations, and Quality consulting, we can readily develop a custom consulting solution to meet your needs. Additional areas of expertise include person-in-the-plant support for your clinical and commercial manufacturing activities, quality assurance auditing, supply chain management consulting, and product launch. Let us know how we can assist you with your project, large or small.
Engineering
- Facility design, project management, and startup
- Manufacturing equipment design, vendor selection, factory acceptance testing, and
installation
- Inspection and packaging equipment design, vendor selection, factory acceptance testing, and installation
Validation
- Master plan creation and review
- Equipment IQ/OQ/PQ
- Critical utility IQ/OQ/PQ
- Process validation
- Media challenge
- Sterility assurance
- Classified environment validation
Operations
- Technical transfer
- Person-in-the-plant oversight during manufacturing, inspection, labeling, and packaging
Quality
- Quality system and cGMP compliance assessment
- Person-in-the-plant oversight
- Vendor audits and qualification
- Regulatory response review
About BioConvergence Consulting Staff
Our experienced consulting team helps you solve problems in many ways.
Our quality assurance / regulatory affairs personnel have experience working with the FDA, MHRA, EMEA, and HCA. Our employees have designed, procured, and commissioned over 100 machines for parenteral cGMP processing. Our employees have served as key contributors on 4 facility expansion projects, including Baxter's facility, which was awarded the 2006 ISPE Facility of the Year Award. Please contact us for more information about our specific qualifications.
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