Vertex BioPharm Consulting (VBC) offers specialized guidance to help companies in the life sciences sector navigate complex challenges, accelerate innovation, and achieve commercial success. These services address everything from product development and regulatory compliance to market strategy and business development
About VBC
Building on deep scientific expertise and global industry experience, VBC integrates CMC, manufacturing, regulatory, and commercial perspectives to deliver practical, execution-focused solutions. We work closely with clients across all stages of development – from early discovery to late-stage commercialization – serving as a trusted partner to reduce risk, optimize decision-making, and drive sustainable growth.
Key services we offered
Check out some interesting facts about our services.
CMC and Regulatory Affairs
VBC help clients in navigating complex regulatory landscapes IND-enabling and BLA, including submissions, compliance, and interactions with agencies like the FDA and EMA
cGMP manufacturing for Drug Substances (DS) and Drug Products (DP)
VBC guide conceptual design in process development Upstream and Downstream unit optimization, analytical assay development, clinical and commercial manufacturing for DS and DP. VBC also support clients in having right and strategic CRO and CDMO partners
GLP/GMP Audit
VBC provides comprehensive GLP and GMP audit in compliance onsite or remote for supply chains, critical raw materials, DS and DP
Corporate Strategy and Investment, In-licensing and Out-licensing
VBC provides strategic planning to help biotech companies with long-term direction, portfolio and platform strategies, fund raising and capital market in partnership with FINRA dealer-broker license
Research and Development (R&D)
VBC provides a clear guidance on R&D strategies, including experimental design, project management, and identifying promising areas for innovation, next generation sequencing bioinformatics, animal designs and execution
Services
What we are good at.
Corporate Legal & Strategic Advisory Services
Chemistry, Manufacturing, and Controls (CMC)
Process Development and Manufacturing of Drug Substance (DS) and Drug Product (DP) and Automation
Regulatory Support of IND-enabling, BLA and NDA
cGMP Facility Build Out, Retrofit, and cGMP Audit
Next Generation Sequencing and Bioinformatics Services
Capital Investment and NewCo
In-licensing and Out-licensing Services
