Cebiphar experts and our preferred partner can provide complete product development and registration.

Whether you are looking to carry out a single study during the development of your product or you are looking for a partner to whom you can outsource the complete drug development process, we have the expertise and experience to support you.

The support encompasses :

  • Pharmaceutical/ biological development
  • Safety projects : environmental safety, user safety, residues
  • Clinical projects : efficacy, PK / PD, Target animal safety, Field trials, Drug resistance
  • Regulatory procedures

More specifically, services consist of :

  • Gap analysis and data audit for your product identifying supported claims and additional data requirements
  • Conducting literature searches and evaluation of published data to support your product
  • Preparation of development plans with estimates of costs and timelines
  • Study design and reporting in compliance with all relevant guidelines
  • Selection of Contract Research Organisations / Contract Manufacturing Organisations to conduct studies
  • Biological development and manufacture: strategic advice and support including process development and validation, QC test development and validation, technology transfer
  • Regulatory procedures: strategic advice & procedural management, Life cycle management, Pharmacovigilance