Pharmaceutical development
Our team offers tailor-made support for all your pharmaceutical development projects, from the initial stages to the marketing authorization (MA) and post MA.
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Our offer
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Throughout the process, Cocipharm supports you with its cutting-edge expertise.
Pre-development and pharmaceutical development
STRATEGY
FORMULATION
SUPPORT
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We help you define your pharmaceutical development strategy and your product's target quality profile (Quality Target Product Profile)
- Generation of a development plan defined by regulatory and technical restrictions
- Provision of a Project Manager
- Selection of CDMO, CMOs
- Support sourcing active ingredients, excipients and packaging items
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Definition of pre-development studies to pharmaceutical development
- Support with formulation and manufacturing process studies based on pharmaceutical development phases
- Support with primary conditioning studies
- Editorial support and review of Part 3 of the MA file (CTD)
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COCIPHARM supports you
through the phases of analytical development, stability studies, pre-clinical and clinical studies, drawing on the expertise of external collaborators.
Investigational Medicines
Due to their additional level of complexity when compared to existing medicines, because of the diversity of clinical studies (Proof of concept, bioequivalence, Phase I, II , III and IV clinical studies) and of the packaging mode adaptation, COCIPHARM acts as an essential expert and partner to accompany you throughout the process of supplying investigational medicines to research sites.
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COCIPHARM support
- Provision of a project manager
- Feasibility study of the investigational medicine (compared to the protocol of the clinical study)
- Design of the therapeutic unit
- Research and qualification of CMOs and CDMOs
- Support with the research of reference medicines
- Label design
- Support with manufacturing and with primary and secondary packaging
Support with masking studies - Support with drafting Specification Files, the Investigational Medicinal Product Documentation (IMPD) or Investigational new Drug (IND)
- Advice on quality management system for investigational medicines
Post MA expertise and advice
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in a nutshell
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Comprehensive pharmaceutical development advice
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Our know-how = your enhanced pharmaceutical performance
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Adaptability : ad-hoc or regular support
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COCIPHARM’s strengths
in Pharmaceutical Development
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Multi-disciplinarity
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Pharmaceutical development strategy
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Development in both Europe and the USA
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Pragmatism
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Technical expertise
Our consultancy aims to be the interface between the pre-clinical and clinical stages