Government Services
We provide project management and subject matter expertise to government agencies for Pharmaceutical and Biotech developments.
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.
Founded
2009
UEI Number
F1ZMR9JAQF23
CAGE Code
9J6F3UEI
Small Business NAICS
541618, 541714, 541713, 541611, 541612, 541715, 541990, 541614, 325412, 541690
SAM Registration
Active
Core Competencies
Comprehensive CMC expertise for government programs
Program Management
Drug Substance Development (Small & Large Molecule)
Drug Product Development (All dosage forms)
Analytical
CMC Regulatory Affairs
CDMO Selection & Management
Supply Chain
Trade Compliance
Logistics
Packaging & Artwork
Quality Management
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 Substance Development through to finished product market launch and commercial growth.
Past Performance
Proven track record across government programs
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.
Ready to move your molecule forward?
Whether you are navigating a complex CMC challenge or planning your next milestone, start a conversation with our team.
