Services

We provide project management and subject matter expertise for Pharmaceutical and Biotech companies.

Verta Life Sciences helps companies excel at every stage of the pharmaceutical & biotech life cycle

We provide project management and subject matter expertise for Pharmaceutical and Biotech companies in the following service areas.

Drug Substance Development

Small Molecule Chemical Drug Substance
Medicinal Chemistry, Pro Drug Development, &
Complex Chemical Synthesis
Large Molecule Biological Drug Substance
Monoclonal Antibody (mAb)​, Microbial Fermentation, & Cell & Gene Therapy
Quality by Design (QbD)​
Process Optimization​
Process Scale Up & Tech transfer​
Process Characterization
Process Qualification
Process Trouble Shooting
CDMO Selection & Management

Drug Product Development

Formulation Development
Injectables, Liquids, Topicals, Inhalations, & Solids
Physical Property Characterization
Manufacturing Process Design
Process Optimization​
Design of Experiments (DoE)
Quality by Design (QbD)​
Scale Up & Tech transfer​
Process Qualification
Process Trouble Shooting
CDMO Selection & Management

Analytical

Analytical Strategy
Analytical Methods
Stability Study Design
Release & Stability Testing
Statistical Data & Interpretation
Bioequivalence waiver approaches
DNA Reactive Impurities
Impurities Risk Assessment
In-vitro Testing (IVRT, IVPT)
Inhalation Performance Testing Expertise
Third Party Lab Selection & Oversight

Regulatory Affairs

Regulatory Strategy & Guidance
Early-stage, Late-stage and Marketing Approval
FDA, MHRA, EMA. WHO, & Other Agencies
Submission Management & Publishing
Marketing Approval
NDA, BLA, ANDA, DMF, MAA, etc.
Post-approval Submissions
sNDA, AR, Variations, etc.

CDMO Selection & Management

Manufacturing & Supply Strategy
Supplier Selection Criteria
Evaluating RFP & Contracts
Operational Capacity Analysis
Technical Capacity Determination
Financial Analysis
Contract Creation & Negotiation
Project Implementation & Management Supply Chain Forecasting
Financial Forecasting
Supplier Performance Management
KPI's, Contract Adherence, Issue Resolution  

Supply Chain, Trade Compliance, & Logistics

Operational Support
Trade Compliance
Import / Export Compliance​, Risk Assessment
Outsourcing/Offshoring Management
Supply Chain Design & Management
Clinical Supply Management
Sales & Operations Planning
Production & Capacity Planning
Logistics Services Provider (LSP) Selection & Management
Training Program Development
Serialization/Track & Trace

Packaging & Artwork

Pack Design & Selection
Secondary Packaging Design & Selection
Packaging Studies
Transport Studies
New Product Logos
Packaging Artwork Design
Regulatory Submission Artwork
Serialization and Barcode Systems
CDMO Selection & Management

Quality Management

Quality Management System (QMS) 
SOPs and Document Systems
Quality Assurance
Document Review & Product Release
SQM & Quality Agreements
Quality Issue Management
Investigations, Deviations, OOS, CC & CAPAs
Gap Assessment & Remediation
Audits of GMP & GLP Facilities,
CDMO's, & PAI Readiness

Expert Witness Support

Case Document Review
Subject Matter Expert Report
Deposition
Trial Testimony

Our Expertise

Examples of work

We have successfully led development activities on numerous projects from the identification, development and implementation of manufacturing processes for biologicals.

  • Developed, transferred and scaled-up engineered growth factors or fusion proteins in E. coli requiring refolding, PEGylation, and other chemistries.
  • Led the purification of secreted proteins in yeast from high solids fermentations.
  • Completed process characterization studies and process validations for registration and commercialization of a monoclonal antibody and tech transferred into multiple CDMO's in record time.
  • Led technology transfer of critical raw material assay and subsequent investigation and resolution of a long-standing issue for marketed monoclonal antibodies.
  • Authored and reviewed biological drug substance sections of regulatory submissions for BLAs/MAAs and INDs/IMPDs.

We have successfully led development activities on numerous projects for small molecule drug substances from the identification, development, and implementation of manufacturing processes.

  • Led development and implementation of synthetic processes for the manufacture of multiple APIs.
  • Delivered API supplies for toxicology and clinical trials (up to Phase 3) - for diverse therapeutic targets such as metabolic, infectious diseases, and oncology.
  • Identified and developed synthetic routes for rapid scale-up for laboratory-based manufacture of API for clinical supplies.
  • Conducted successful technical transfer and validation of commercial manufacturing processes.
  • Applied Quality by Design (QbD) principles to drug substance synthesis.
  • Authored and reviewed drug substance sections of regulatory submissions for BLAs/MAAs and INDs/IMPDs.

Verta Life Sciences consultants have experience developing drug products in all dosage forms using a variety of technologies.

  • Scaled-up and Tech Transferred aseptic fill/finish manufacturing for multiple sterile products including vials, ampules, and pre-filled syringes.
  • Designed solid dose form using process design and optimization for multiple tablet, hard and soft gel capsules products.
  • Led inhalation product development and scale up for clinical and commercial supplies
  • Managed scale-up and troubleshooting during clinical trials/regulatory batch production for solid dose products manufactured using Blending/Granulation/Drying.
  • Reviewed methodology, support process trials and tech transfer for products using Suspension/Bead Milling.
  • Reviewed facilities and produced equipment rationalization paper for mixing, granulating and FBD processing worldwide.
  • Authored and reviewed drug product sections of regulatory submissions for BLAs/MAAs and INDs/IMPDs.

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.

  • Implemented automation for complex analytical testing for inhalation products and successfully led tech transfer of these platforms to manufacturing sites.
  • 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.
  • Completed multiple analytical method transfers and validation applying QbD principles.
  • Authored stability study protocol to ensure alignment with ICH and market-specific regulations.

Verta Life Sciences consultants have helped clients register numerous products with the US FDA, EMA, MHRA, WHO, and other regulatory agencies worldwide.

  • Developed regulatory strategies for product development, approval, market launch and supply continuity.
  • Authored IND Module 2 (Product Development Rationale) and Module 3 (all sections) for multiple products and all dosage forms.
  • Submitted BLAs for biologics and combination products in over 95 countries including USA, EU, UK and China.
  • Ex-UK MHRA Assessor support for all types of biological products including monoclonal antibodies, peptides, vaccines, blood products and gene therapy products.
  • Reviewed and edited the Pharmaceutical Development Section of an ANDA for a company’s initial entry into the US market.
  • Supported multiple submissions for IND/IMPD/CTA for biologics and Cell/Gene therapy pipeline.
  • Guided an EU client through the regulatory process and development requirements to market an Oral Care OTC Drug Product portfolio in the US.

On behalf of our clients, we work with contract manufacturers worldwide to ensure the successful development, tech transfer and supply of APIs.

  • Led the entire CMC program for a potential monoclonal antibody COVID treatment.
  • Rapidly scaled-up, tech transferred, and managed the selection and management of 7 CDMO's involved in BDS manufacture, DP fill finish, and clinical packaging.
  • Conducted due diligence review, contract negotiation, tech transfer management, new product launch planning on behalf of numerous clients.
  • Led a review of the manufacturing and supply strategies being implemented by 11 different CDMO's to ensure the secure and affordable supply of the clients products.
  • Negotiated supply, technical transfer, master service and development agreements for numerous clients with product in per-IND phase through to commercial supply.

Our consultants have managed operational logistics activities from new drug investigation through commercial launch for numerous clients.

  • 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.
  • Conducted numerous sourcing activities to identify, select, onboard and manage LSP’s best suited for client needs.
  • 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.
  • Implemented new warehousing strategy to improve delivery times to customers and for business continuity.
  • Lead and provided oversight for a high volume national medical aesthetics  manufacturing operation.
  • Implemented a global trade compliance solution minimizing risk and saving $50M in first year through duty  optimization in a major pharmaceutical company.

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.

  • Established end to end package design, development and qualification processes for consumer and pharmaceutical products
  • Created packaging design for all types of dosage forms.
  • Lead serialization implementation for Specialty Care products through collaboration with partners and their CMOs.
  • Created artwork for multiple products in including pack design, prescribing and patient information insert and outsert design, editing and proof reading in english and other languages.
  • Directed serialization project, including MDM and ERP system for a major gene therapy company.

In response to increasingly stringent regulatory requirements, we provide comprehensive quality management support.

  • Developed and implemented phase appropriate quality management systems for multiple development companies.
  • Implemented and performed quality system remediation activities including quality system redesign of document control, change control, investigation, and complaint systems.
  • Conducted GMP, GLP, GDP, and Global Clinical Quality audits globally for clients.
  • Provided quality oversight of contract manufacturers, alliance partners and subsidiaries from initiation of commercial manufacturing to termination of relationship.
  • Acted as a liaison during regulatory inspections (i.e., general inspections, pre-approval inspections, and site inspections). Coordinated written responses to any comments/observation. Coordinated product recalls and provided FDA with periodic status reports.
  • Acted as Japan quality lead for Medical device and Alliance relationship.
  • Acted as China quality lead for multiple products.
Large Molecule Drug Substance
Small Molecule Drug Substance
Drug Product Development
Analytical
Regulatory Affairs
CDMO Selection & Management
Supply Chain, Trade Compliance, & Logistics
Packaging & Artwork
Quality Management
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