Pharmaceutical

Industrialization

COCIPHARM CONSULT supports your industrialization projects – whether launching production or relocating your manufacturing site. We provide expert guidance at every stage of the process

Change of site

Scaling-up

Product launches

Pharmaceutical

Industrialization

OUR OFFER

Pharmaceutical industrialization presents significant challenges, particularly for small or medium-sized companies without internal resources.

Our action

In Europe and Internationally

In strict compliance with GMP regulations and international standards (ICH, Ph Eur, USP)

  • Selection and evaluation of CMOs or CDMOs

  • Assistance with sourcing raw materials and packaging components

  • Definition of an industrial transfer strategy aligned with regulatory requirements

  • Preliminary steps: risk analysis, requirements specifications

  • Operational follow-up of transfer steps

  • Guidance on transfer documentation

  • Process validation (definition of Critical Process Parameters and Critical Control Points)

  • Change management strategy and support for variation filings

Facilitation

A Trusted Expert to Secure the Process

Our specialists act as your strategic intermediaries, ensuring your industrialization and regulatory procedures are executed according to best practices and current standard.

Facilitation

A Trusted Expert to Secure the Process

Our specialists act as your strategic intermediaries, ensuring your industrialization and regulatory procedures are executed according to best practices and current standard.

Our support

An expert at your side throughout the manufacturing process

From initial planning to product launch and throughout the entire product lifecycle, our experts provide end-to-end support for your manufacturing activities.

Our support

An expert at your side throughout the manufacturing process

From initial planning to product launch and throughout the entire product lifecycle, our experts provide end-to-end support for your manufacturing activities.

Our expert at the heart of the transfer process

To ensure the success of your project, your dedicated COCIPHARM Project Manager will:

  • Coordinate and oversee all stages of the industrial transfer.

  • Thanks to his/her role as coordinator and his/her technical expertise, (s)he guarantees your project’s success

  • Serve as a consistent point of contact for internal and external stakeholders

  • Deliver continuous monitoring and follow-up to drive project success

COCIPHARM CONSULT

Industrial Expertise

Trouble-Shooting resolution

Continuous process improvement recommendation

Compliance with French and international regulations

Expert selection and evaluation of CMOs

Practical, solution-oriented technical support

A pragmatic and results-driven approach

Expertise on different pharmaceutical forms

Sterile and non-sterile processes (solid forms, pasty and liquid forms, multidose and single dose…)

Small molecules

Low-dose active substances (hormones, cytotoxics)

Corinne CIAPPARA

CMC Consultant & Director

330 boulevard de la Madeleine

06000 NICE – France

info@cocipharm-consult.com

+33 (0)6 81 41 68 16

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