Government Services

Verta Life Sciences is a USA-based Chemistry, Manufacturing and Controls (CMC) consulting and product management firm which supports pharmaceutical, biotech and medical device developments.

Serving government agencies with a comprehensive range of CMC services from early stage pre-clinical through phase I, II and III clinical studies to registration and commercial supply.

• Verta Life Sciences was founded in 2009
• UEI Number: F1ZMR9JAQF23
• Cage Code: 9J6F3UEI
• Small Business NAICS – 541618, 541714, 541713, 541611, 541612, 541715, 541990, 541614, 325412, 541690
• SAM Registration: Active
  

SAM Competency Statement

‍Verta Life Sciences is a USA-based international Chemistry, Manufacturing and Controls (CMC) Consulting and Product Management Firm which supports the Pharmaceutical, Biotech and Medical Device Industries. The majority of our subject matter experts have more than 25 years of experience providing extensive support in all areas of development programs, from Pre-Clinical to NDA/BLA Submission. The services include small and large molecule product development, quality and regulatory compliance, managing manufacturing, supply and distribution, launching life science products globally and managing strategic programs from Pre-clinical Drug SubstanceDevelopment through to finished product market launch and commercial growth.

• Large Molecule Development: Verta has successfully led development of numerous large molecule projects, from identifying, developing and implementing and commercializing manufacturing processes for biologics - Monoclonal Antibodies (mAbs), Microbial Fermentation, and Cell & Gene Therapy.
  
• Small Molecule Drug Substance Development: Verta has successfully led the development and implementation of complex synthetic processes for the manufacture of multiple APIs.
• Drug Product Development: Verta consultants have expertise in developing drug products in all dosage forms using a variety of technologies such as aseptic fill/finish of vials, ampules, and pre-filled syringes, tablets, hard and soft gel capsules, topicals, semi-solids, inhalations, and combination devices.
• Analytical Development: Analytical methodology is critical to drug development, from drug discovery to post-approval. Verta has expertise in developing analytical methodology for all phases of product development and supporting ongoing stability studies for our clients.
• Packaging and Artwork: We have worked on over 100 new product launches, including primary and secondary package design, new product logos and production artwork.
• CDMO Selection & Management: On behalf of our clients, we select and manage contract development and manufacturers worldwide to ensure the successful development, tech transfer, and supply of our clients' BDS, API, DP, packaging, clinical, and commercial supplies.
• Supply Chain, Trade Compliance & Logistics Management: We manage operational logistics activities from new drug investigation through commercial launch for numerous clients.
• CMC Regulatory Affairs: Verta consultants have successfully helped clients register numerous products with the US FDA, EMA, MHRA, WHO, and other regulatory agencies worldwide. We author IND Module 2 (Product Development Rationale) and Module 3 (all sections) for biologic and small molecule products and all dosage forms and have submitted INDs/IMPDs/CTAs/NDAs and BLAs in over 95 countries, including the USA, EU, UK and China.
• Quality Management: We provide comprehensive quality management support in response to increasingly stringent regulatory requirements, including developing and implementing phase-appropriate quality management systems and conducting GCP, GMP, GLP, and GDP Quality audits globally for clients.