CDMO Vendor Selection Qualification and Oversight

A well-chosen Contract Development and Manufacturing Organization (CDMO) can simplify your own work processes, reduce risks, and prevent non- compliance with regulations all through the entire product lifecycle.

At BioBoston Consulting we provide much more than just CDMO Vendor Selection, Qualification, and Oversight services to make sure you settle productive partnerships which meet your company’s needs.

Why Choose BioBoston Consulting for CDMO Vendor Selection, Qualification & Oversight?

Strategic CDMO selection

With many years’ experience working in the pharmaceutical, biotech and medical device industry, we understand the complexity of outsourcing to a CDMO. Our team brings knowledge and expertise to choose correctly qualified CDMO partners for your program.

For every client, our CDMO selection process is tailor- made so that as much as possible its individual needs are met; whether in terms of technical capabilities, regulatory guidance and support capacities.

Focus on Regulatory Compliance

All of our selected CDMOs should meet cGMP.

Using our extensive global network of CDMO partners, you’ll find just the right partner for your project. We partner with top-tier vendors who meet your technical and regulatory needs.

Qualification Audits for CDMOs

Thoroughly auditing the production capacity of potential CDMOs and how they are structured up according to industrial regulations such as cGMP.

Contracting and Managing

Helping to agree reasonable terms with your chosen CDMO with the result both clear project deliverables and timelines.

Risk Analysis

Conducting an assessment of risk to identify possible CHALLENGES in CDMO performance, quality control, or compliance with regulations, come up with plans for addressing these risks throughout project lifecycles.

Performance Monitoring of CDMOs

Once a CDMO has been chosen, we can also continue to watch over it. We monitor performance in general; projects have timelines complied with as part of successful completion and quality problems are recognized in time.

Providing ongoing monitoring and reporting on the performance to ensure that your CDMO stays committed, maximizes value- added benefits and works within defined timeframes and regulatory requirements.

Management of Corrective and Preventive Actions (CAPA)

Supervising the development and implementation CDMO takes to address quality issues that arise in the manufacturing processes.

Turn Development and Manufacturing with BioBoston Consulting

Our CDMO Vendor Selection, Qualification & Oversight services ensure that life sciences companies have the expertise and support required to put their development and manufacturing into capable hands. Let us help you pick the best CDMO for your program’s technological, regulatory, and operational needs.

Get in Touch

Contact us to know more about how BioBoston Consulting can help with your CDMO supplier selection, qualification and inspection needs.