Molecule to Market Consulting

Posted by & filed under New Product Registration & Launch

Verta Life Sciences is an International Consulting and Product Management company that supports Life Science Companies, Develop, Register, Launch and Ensure the Supply of their Products.

In the last two years alone we have helped clients develop, register and launch 5 New Products.

We work with clients to ensure that their product’s; manufacturing processes are robust and repeatable, packaging design and artwork are in place and serialized, the CMC package is complete, supply chains are launch-ready and that they have mitigated any risks that might prevent a successful registration and launch.

We have experts in:

Technical: Assessments and Support

·         Development and Regulatory Strategy
·         Small and Large Molecule Development
·         Formulation Development and Scale Up
·         Polymeric Controlled Release Systems
·         Medical Device Design
·         Primary (API) & Secondary (Drug Product)
·         Quality by Design (QbD)
·         CMC Regulatory
·         Post Approval Regulatory
·         Degradation Chemistry
·         Physico-chemical Characterization
·         Analytical Development
·         Stability Support
·         Packaging Engineering and Design
·         Serialization
·         Artwork Design and Production
·         Quality Management Systems
.         Data Integrity
·         GxP Compliance Auditing

 

Operational: New Product Registration, Launch, and Supply

·         Manufacturing and Supply Strategy
·         CMO Selection, Contracting, and Management
·         Logistics Service Provider Selection and Management
·         Technology Transfer
·         Process & Analytical Methods Validation Quality Management
·         LEAN Six Sigma Continuous Improvement & Process Understanding
·         Cost of Goods Analysis and Reduction
·         Supply Chain Management
·         Manufacturing and Supply Risk Reduction
·         New Product Launch
·         Sales and Operational Planning

 

Examples of New Product Development, Registration, and launch Support:

Sterile Liquid Product:

  • Manufacturing and Supply Strategy
  • Logistics service provider selection
  • Validation and PAI status review
  • QA Audits, QMS Review, and Upgrade Support
  • Packaging & Artwork Design
  • Launch Planning and Support

Aseptic Dry Powder Product:

  • Manufacturing and Supply Strategy
  • CMO Selection and Contract Negotiation
  • Tech Transfer, and Scale-up
  • Degradation Chemistry Review
  • Analytical Method Development and Validation
  • CMO Oversight during Registration and Validation batch manufacture

Solid Dose (Capsule) Product:

  • Manufacturing and Supply Strategy
  • CMO Selection and Contract Negotiation
  • Tech Transfer, and Scale-up
  • CMO Oversight during Registration and Validation batch manufacture
  • Packaging & Artwork Design
  • CMC Module 3 Writing
  • Manufacturing Launch Strategy and Planning
  • Staff Recruitment and Selection
  • QMS Review and Upgrade Support

Solid Dose (Tablet) Product:

  • Manufacturing and Supply Strategy
  • QA Audits and Support
  • Packaging & Artwork Design
  • Manufacturing Launch Strategy and Planning

Topical Foam Product:

  • CMO Selection and Contract Negotiation
  • Degradation Chemistry Review
  • Analytical Method Development and Validation
  • Process Engineering Support
  • CMO Oversight during Registration and Validation batch manufacture
  • Packaging & Artwork Design
  • QA Management and Support
  • QMS Implementation

Inhaled Product:

  • Manufacturing and Supply Strategy
  • Degradation Chemistry Review

Drug Eluding Device:

  • Manufacturing and Supply Strategy
  • Alternative manufacturing site due diligence and contract negotiation
  • Packaging Design
  • Launch planning

Our consultants have the expertise and experience to ensure successful registration and launch of Life Science products. All our consultants have 20+ years of experience and can bring proven track records of success to your projects.

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