Services
We provide project management and subject matter expertise for Pharmaceutical and Biotech companies.
We provide project management and subject matter expertise for Pharmaceutical and Biotech companies.
We provide project management and subject matter expertise for Pharmaceutical and Biotech companies in the following service areas.
Small Molecule Chemical Drug Substance
Medicinal Chemistry, Pro Drug Development, &
Complex Chemical Synthesis
Large Molecule Biologic 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
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 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 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.
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
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
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 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
Case Document Review
Subject Matter Expert Report
Deposition
Trial Testimony
We have successfully led development activities on numerous projects from the identification, development and implementation of manufacturing processes for biologics - Monoclonal Antibodies (mAbs), Microbial Fermentation, & Cell & Gene Therapy.
We have successfully led development activities on numerous projects for small molecule drug substances from the identification, development, and implementation of manufacturing processes.
Verta Life Sciences consultants have experience developing drug products in all dosage forms using a variety of technologies.
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.
Verta Life Sciences consultants have helped clients register numerous products with the US FDA, EMA, MHRA, WHO, and other regulatory agencies worldwide.
On behalf of our clients, we work with contract manufacturers worldwide to ensure the successful development, tech transfer and supply of APIs.
Our consultants have managed operational logistics activities from new drug investigation through commercial launch for numerous clients.
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.
In response to increasingly stringent regulatory requirements, we provide comprehensive quality management support.
Please complete the contact form below and let us know how we can be of service to your organization.