End-to-end services

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EVALUATION

Experienced Portfolio Team

  • Market & trends
  • Product idea
  • Line extensions
  • Project design

 

PRE-FORMULATION

State-of-the-art facilities

Designing around patents

API

  • Literature search
  • Risk analysis
  • Physicochemical characterization
  • Reverse engineering
  • API & raw materials in-house development/ sourcing

 

DEVELOPMENT

Wide range of dosage forms

Modern technologies & equipment

Added value generics development

  • Quality by Design (QbD)
  • Formulation and process
  • Scale up
  • Technology Transfer
  • Clinical / registration batches
  • Stability studies Dossier

 

MANUFACTURING

GMP pilot facility

Flexible batch sizes

Off-site production experience

  • Mass production
  • Clinical/registration batches
  • Packaging
  • Quality assurance

 

REGISTRATION LAUNCH

Excellent products with CTD/eCTD dossiers (meeting EU, CA, AU, BR, EAEU, CIS & UA requirements)

Day One Launch

  • Dossier submission & registration process
  • Launch preparation – Process validation PPH or TT to CMO

 

SUPPORTING SERVICES

  • Regulatory affairs
  • Intellectual property
  • Project management

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