Pharmaceutical

Development

Our Team provides customized support for all your pharmaceutical development projects – from the earliest stages through to Marketing Authorization (MA) and beyond.

Let’s discuss your project

Pharmaceutical

Development

Our Team provides customized support for all your pharmaceutical development projects – from the earliest stages through to Marketing Authorization (MA) and beyond.

Let’s discuss your project

CMC Development Strategy

Technical and strategic advice

Projects in Europe and the USA

Pharmaceutical

Development Services

OUR OFFER

Our consultancy supports pharmaceutical companies at every step of their development projects, from the initial stages to market launch.
With cutting-edge expertise and a deep understanding of regulatory and scientific challenges, COCIPHARM CONSULT is your trusted partner throughout the entire process

Pre-Development

and Pharmaceutical

Development

Let’s discuss your project

STRATEGY

DEFINITION OF YOUR pharmaceutical development strategy and Quality Target Product Profile (QTPP)

Development of a strategy based on regulatory and technical constraints
Preparation of a detailed development plan
Assignment of a dedicated Project Manager
Selection and qualification of CDMOs and CMOs
Support in sourcing active ingredients, excipients, and packaging materials

FORMULATION

From Pre-Formulation Studies to Prototypes

Support with formulation development and manufacturing process studies based on pharmaceutical development phases
Support with studies on primary packaging compatibility and performance
Editorial support and review of Module 3 of the Marketing Authorisation (MA) dossier (Common Technical Documentation – CTD)

SUPPORT

COCIPHARM CONSULT IS BY YOUR SIDE

Throughout analytical development, stability studies, pre-clinical and clinical studies we support you with the help of our network of experienced external collaborators.

Investigational Medicinal Products

our Expert Partner in Supplying Investigational Medicinal Products (IMP) to Clinical Sites
COCIPHARM CONSULT provides end-to-end support for the supply of investigational medicinal products (IMPs), ensuring compliance, quality, and feasibility

Provision of a dedicated Project Manager
Feasibility study of the IMP in line with clinical trial protocols
Design of the therapeutic unit presentation
Identification and qualification of CMOs and CDMOs
Support in sourcing reference medicinal products
Label design and regulatory review
Support with manufacturing, primary and secondary packaging
Support with masking and blinding studies
Preparation of Specification Files, Investigational Medicinal Product Documentation (IMPD) or Investigational new Drug (IND)
Guidance on implementing and maintaining a Quality Management System (QMS) throughout the IMP lifecycle

Post Marketing Authorization Expertise and Advice

Completion of Due Diligence of MA module 3 files for new product acquisitions
Technical File Audits (Gap Analysis)
Galenic expertise in solid, semi-solid and liquid forms, including multi-doses and sterile unidoses presentation, as well as novel pharmaceutical forms
Regulatory maintenance and change management (handling of regulatory variations)

Our difference

End-to-End Pharmaceutical Development Guidance

Our expertise supports the performance of your pharmaceutical projects through a tailored, pragmatic approach.

Adaptability:
Flexible support — ad hoc or continuous

Holistic Know-How:
Leveraging deep knowledge to improve your development efficiency

Let’s discuss your project

COCIPHARM CONSULT’s

Strengths

Multi-disciplinarity expertise

Pharmaceutical development strategy

In-depth knowledge of diverse pharmaceutical dosage forms

Proven experience in both European and U.S. regulatory environments

Technical and practical mindset, focused on operational feasibility

CONTACT OUR EXPERTS

We act as the key interface between pre-clinical and clinical development stages — enabling a seamless transition from concept to market.

Corinne CIAPPARA

CMC Consultant & Director

330 boulevard de la Madeleine

06000 NICE – France

info@cocipharm-consult.com

+33 (0)6 81 41 68 16