API Development

production machinery in pharmaceutical facility

Based in Portugal, Chartwell Actives, LLC., is an API scientific and business team specializing in fermentation, downstream processing and chemical synthesis. The team has decades of combined experience in GMP applied to API manufacturing, research and development, engineering, quality control, quality assurance, and regulatory affairs in a US FDA and an EU Evaluation of Medicinal Products (EMEA) environment. By integrating the API, Finished Dose Forms (FDF), and commercialization chain, Chartwell will be able to meet the needs of a growing market for hard-to-find, complex drugs being developed for commercial approval.

The Actives team is a cornerstone of Chartwell's vertical expansion, with relationships in the US, EU, and Asian markets.

Supported on its network of key partnerships, Chartwell Actives is actively engaged in managing the life cycle of both APIs and FDFs together with its customers adding value to their portfolios. We aim to bring value to our clients in the following areas:

  • API Development and Tech Transfer
    • Co-developments with EU partners - from API2FDF
    • Strong technical and scientific network
    • Strain Engineering & Optimization
    • DSP Development
    • Bio-Process Development
    • Chemistry
  • API Portfolio management and marketing
    • Promoting quality APIs from selected manufacturing partners
  • Co-development and licensing strategies
    • In-licensing and Out-licensing strategies
    • Co-developments
    • Special FDFs
  • Engineering & Project
    • Green/Brown field Bio Facilities engineering /procurement/validation/ commissioning
    • Project/construction/start-up via Modularization Strategy; Modular Engineering and Construction, speeding up the delivery of a plant when compared with traditional approaches
  • API Portfolio management and marketing
    • DMF, ANDA/NDA & MA registrations
    • Pharmacovigilance for all of Chartwell Pharmaceuticals NDA / ANDAs
    • Gap-analysis API&FDF
    • Suppliers qualification
    • Validations (Process, Methods, Cleaning)

Manuel Eduardo Fernandes
General Manager, Chartwell Actives Portugal

Manuel brings a deep well of expertise to Chartwell Actives. He has over 26 years of experience in the API industry with over 10 years as a site manager for Cipan, a Portugal fermentation-based API manufacturer. Manuel served primarily US businesses in an advisory capacity including two new Atral-Cipan API facilities where he was general manager of engineering for construction, commissioning and validation of new API facilites.

Manuel obtained a BSc and MSc in Chemical Engineering from the Instituto Superior Tècnico (Lisbon Technical University) and an MBA from the Portuguese Catholic University.

Chartwell Pharmaceuticals