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