Quality Assurance

Our consultancy provides you with its expertise in organizing and managing quality assurance, in accordance with current regulations.

Quality Assurance

Our consultancy provides you with its expertise in organizing and managing quality assurance, in full compliance with current regulatory standards.

Quality Assurance (QMS)

Preparation and monitoring of regulatory inspections

Pharmaceutical responsibility

Quality Assurance for the Pharmaceutical Industry

OUR OFFER

The implementation or evolution of a Quality Management System (QMS) within a pharmaceutical company is a strategic decision that must not be left to chance.

Our experienced team is here to support you to guarantee a QMS adapted to your quality policy, your operational environment and the current regulatory requirements.

Tailored support

Targeted support for solving your specific Quality Assurance challenges

Quality assurance systems designed to meet your needs and comply with applicable regulations

Consulting and Support for QMS implementation and updates

  • Manufacturing sites

  • Exploitant sites

  • Investigational Medicinal Products (IMP) manufacturing sites

Consulting and Support for QMS implementation and updates

  • Manufacturing sites

  • Exploitant sites

  • Investigational Medicinal Products (IMP) manufacturing sites

Internal or external audits

  • Subcontractors

  • CMOs, CDMOs
  • Distributors, call centers…

  • Internal services

Internal or external audits

  • Subcontractors

  • CMOs, CDMOs
  • Distributors, call centers…

  • Internal services

Management of external partners

Selection and qualification

  • CMOs, CDMOs

  • Service providers
  • Distributors

Management of external partners

Selection and qualification

  • CMOs, CDMOs

  • Service providers
  • Distributors

Additional services by COCIPHARM CONSULT

  • Management of preventive and corrective actions for deviations and complaints

  • Product quality reviews (PQRs)

  • Preparation and monitoring of regulatory inspections

  • Definition and monitoring of quality indicators (KPIs)

Additional services by COCIPHARM CONSULT

  • Management of preventive and corrective actions for deviations and complaints

  • Product quality reviews (PQRs)

  • Preparation and monitoring of regulatory inspections

  • Definition and monitoring of quality indicators (KPIs)

Why choose COCIPHARM CONSULT?

Proven Field experience

A dedicated Project Manager

In-depth technical and regulatory expertise

QMS know-how tailored to your context

Flexibility and pragmatic solutions

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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