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.

Let's discuss your project
CMC Development Strategy
Technical and strategic advice
Projects in Europe and the USA
Pharmaceutical development

Our offer

Our consultancy supports pharmaceutical companies in their development projects from the initial stages to their market launch.
Throughout the process, Cocipharm supports you with its cutting-edge expertise.

Pre-development and pharmaceutical development

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STRATEGY

FORMULATION

SUPPORT

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

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)

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

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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.

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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Completion of Due Diligence of MA module 3 files for new product acquisition
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Technical File Audits (Gap Analysis)
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Galenic expertise (solid, semi-solid and liquid forms, multi-doses and sterile uni-doses, new pharmaceutical forms)
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Regulatory maintenance and change management (regulatory variations)
Our difference

in a nutshell

Comprehensive pharmaceutical development advice

Our know-how = your enhanced pharmaceutical performance

Adaptability : ad-hoc or regular support

COCIPHARM’s strengths

in Pharmaceutical Development

Multi-disciplinarity

Pharmaceutical development strategy

Knowledge of different pharmaceutical forms

Development in both Europe and the USA

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Pragmatism

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Technical expertise

CONTACT COCIPHARM EXPERTS

Our consultancy aims to be the interface between the pre-clinical and clinical stages

Corinne CIAPPARA
CMC Consultant & Président
330 boulevard de la Madeleine
06300 NICE - France

info@cocipharm.com
+33 (0)6 81 41 68 16