CMC Product development

Product development : Supporting the development of the best product while ensuring quality compliance

Pharmaceutical Development

Supporting the development of the best product while ensuring quality compliance

 

  • Strategic consultancy during global pharmaceutical development and lifecycle management
  • Expertise in all types of API (chemical, biological, herbals) – Development of ASMF, DMF, CEP
  • Strategic advices in drug product development and coordination of activities as formulation, process, analytical development and validation, specifications, stability studies design, setting of shelf life
  • Decision making to drive investments: due diligence, gap analysis and experts reviews

Project Management

Coordination of all activities in pharmaceutical development from product development to registration and geographical roll out

 

  • Establish project objectives whith client and define strategy for managing the project
  • Manage risks, control schedule, cost, resources, quality
  • Manage teams, workstreams, communication (meeting minutes, review of deliverables), changes
  • Identify, manage and coordinate analytical or manufacturing subcontractors

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