Services
We provide project management and subject matter expertise for Pharmaceutical and Biotech companies in the following service areas.
Service Area
Drug Substance Development
Examples of Work
Large Molecule
We have successfully led development activities on numerous projects from the identification, development and implementation of manufacturing processes for biologics - Monoclonal Antibodies (mAbs) and Microbial Fermentation.
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Developed, transferred and scaled-up engineered growth factors or fusion proteins in E. coli requiring refolding, PEGylation, and other chemistries.
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Led the purification of secreted proteins in yeast from high solids fermentations.
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Completed process characterization studies and process validations for registration and commercialization of a monoclonal antibody and tech transferred into multiple CDMOs in record time.
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Led technology transfer of critical raw material assay and subsequent investigation and resolution of a long-standing issue for marketed monoclonal antibodies.
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Authored and reviewed biological drug substance sections of regulatory submissions for BLAs/MAAs and INDs/IMPDs.
Small Molecule
We have successfully led development activities on numerous projects for small molecule drug substances from the identification, development, and implementation of manufacturing processes.
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Led development and implementation of synthetic processes for the manufacture of multiple APIs.
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Delivered API supplies for toxicology and clinical trials (up to Phase 3) for diverse therapeutic targets such as metabolic, infectious diseases, and oncology.
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Identified and developed synthetic routes for rapid scale-up for laboratory-based manufacture of API for clinical supplies.
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Conducted successful technical transfer and validation of commercial manufacturing processes.
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Applied Quality by Design (QbD) principles to drug substance synthesis.
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Authored and reviewed drug substance sections of regulatory submissions for NDAs/MAAs and INDs/IMPDs.
Service Area
Drug Product Development
Examples of Work
Verta Life Sciences consultants have experience developing drug products in all dosage forms using a variety of technologies.
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Scaled-up and Tech Transferred aseptic fill/finish manufacturing for multiple sterile products including vials, ampules, and pre-filled syringes.
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Designed solid dose form using process design and optimization for multiple tablet, hard and soft gel capsules products.
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Led inhalation product development and scale up for clinical and commercial supplies.
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Managed scale-up and troubleshooting during clinical trials/regulatory batch production for solid dose products manufactured using Blending/Granulation/Drying.
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Reviewed methodology, support process trials and tech transfer for products using Suspension/Bead Milling.
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Reviewed facilities and produced equipment rationalization paper for mixing, granulating and FBD processing worldwide.
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Authored and reviewed drug product sections of regulatory submissions for NDAs/BLAs/MAAs/ANDAs/sNDAs/ and INDs/IMPDs.
Service Area
Analytical
Examples of Work
Analytical methodology is critical to the drug development process from drug discovery to post-approval. We have the experience developing analytical methodology for all phases of product development.
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Implemented automation for complex analytical testing for inhalation products and successfully led tech transfer of these platforms to manufacturing sites.
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Developed a robust risk-based approach to qualify and release test over 90 new raw materials for semi solid topical products over an 18-month period.
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Supported USP Heparin Advisory Panel, consisting of FDA/industry/academic members, that introduced a revolutionary new heparin monograph to the industry to modernize heparin testing to protect public safety.
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Completed multiple analytical method transfers and validation applying QbD principles.
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Authored stability study protocol to ensure alignment with ICH and market-specific regulations.
Service Area
Regulatory Affairs
Examples of Work
Verta Life Sciences consultants have helped clients register numerous products with the US FDA, EMA, MHRA, WHO, and other regulatory agencies worldwide, including the USA, EU, UK and China.
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Developed regulatory strategies for product development, approval, market launch and supply continuity.
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Authored IND Module 2 (Product Development Rationale) and Module 3 (all sections) for multiple products and all dosage forms.
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Submitted BLAs/MAAs for biologics, and NDAs/MAAs for pharmaceutical and combination products worldwide, including the USA, EU, UK and China.
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Supported client acquiring product developed in China, converting Chinese module 3 and QOS into format required for submission to the US FDA IND and EU EMA IMPD for phase III clinical studies.
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Reviewed and edited the Pharmaceutical Development Section of an ANDA for a company's initial entry into the US market.
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Supported multiple submissions for IND/IMPD/CTA for biologics and Cell/Gene therapy pipeline.
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Guided an EU client through the regulatory process and development requirements to market an Oral Care OTC Drug Product portfolio in the US.
Service Area
CDMO Selection & Management
Examples of Work
On behalf of our clients, we work with contract manufacturers worldwide to ensure the successful development, tech transfer and supply of APIs.
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Led the entire CMC program for a potential monoclonal antibody COVID treatment.
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Rapidly scaled-up, tech transferred, and managed the selection and management of 7 CDMOs involved in BDS manufacture, DP fill finish, and clinical packaging.
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Conducted due diligence review, contract negotiation, tech transfer management, new product launch planning on behalf of numerous clients.
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Led a review of the manufacturing and supply strategies being implemented by 11 different CDMOs to ensure the secure and affordable supply of the clients' products.
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Negotiated supply, technical transfer, master service and development agreements for numerous clients with product in pre-IND phase through to commercial supply.
Service Area
Supply Chain, Trade Compliance, & Logistics
Examples of Work
Our consultants have managed operational logistics activities from new drug investigation through commercial launch for numerous clients.
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Directed a supply chain program that impacted 151 markets and 99 manufacturing sites in 39 countries. Instrumental in delivering $1.8 billion in annual savings.
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Conducted numerous sourcing activities to identify, select, onboard and manage LSPs best suited for client needs.
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Re-routed client's international supply chain resulting in reduction in clearance and overall shipping times, reduction in risk of loss, and reduction in costs by 50% per shipment.
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Implemented new warehousing strategy to improve delivery times to customers and for business continuity.
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Led and provided oversight for a high volume national medical aesthetics manufacturing operation.
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Implemented a global trade compliance solution minimizing risk and saving $50M in first year through duty optimization in a major pharmaceutical company.
Service Area
Packaging & Artwork
Examples of Work
We have worked on over 100 new product launches that included both primary and secondary package design, as well as new product logos and production artwork.
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Established end-to-end package design, development and qualification processes for consumer and pharmaceutical products.
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Created packaging design for all types of dosage forms.
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Led serialization implementation for Specialty Care products through collaboration with partners and their CMOs.
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Created artwork for multiple products including pack design, prescribing and patient information insert and outsert design, editing and proof reading in English and other languages.
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Directed serialization project, including MDM and ERP system for a major gene therapy company.
Service Area
Quality Management
Examples of Work
In response to increasingly stringent regulatory requirements, we provide comprehensive quality management support.
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Developed and implemented phase appropriate quality management systems for multiple development companies.
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Implemented and performed quality system remediation activities including quality system redesign of document control, change control, investigation, and complaint systems.
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Conducted GMP, GLP, GDP, and Global Clinical Quality audits globally for clients.
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Provided quality oversight of contract manufacturers, alliance partners and subsidiaries from initiation of commercial manufacturing to termination of relationship.
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Acted as a liaison during regulatory inspections (general inspections, pre-approval inspections, and site inspections). Coordinated written responses to any comments/observations. Coordinated product recalls and provided FDA with periodic status reports.
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Acted as Japan quality lead for Medical device and Alliance relationship.
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Acted as China quality lead for multiple products.
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China-based GMP audits of Chinese CDMOs on behalf of numerous clients.
Service Area
China Support Services
Helping U.S. Biotech Acquire Chinese Molecules and Advance Clinical Trials
Verta supports U.S. biotech and pharma companies evaluating partnerships with Chinese innovators—from technical and regulatory due diligence through the documentation needed to advance candidates in Western markets.
See blog postGMP Audits in China
As global supply chains expand, ensuring compliance with multiple regulatory frameworks is essential for pharmaceutical and biotechnology companies operating internationally. At Verta, we support this need by delivering GMP audits in China that align not only with local regulations, but also with the stringent expectations of the US FDA and EU EMA authorities.
By combining global regulatory expertise with in-country execution, we help clients maintain compliance across all major markets—without compromise.
Tech Transfer and Registration in China
Helping clients with tech transfer into China and registration of US/EU products with the Chinese regulatory agency.
Tech Transfer Out of China
Helping clients with tech transfer of drug substance and drug product manufacture from China into US/EU CDMOs.
Service Area
Expert Witness Support
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