PROJECTS

Technology transfer of the manufacturing process for an oral solid product

Client: a company that has always been involved in the research, development and marketing of innovative drugs.

Sector: Pharmaceutical

Objective: management of technology transfer activities for the manufacturing process of an oral solid product from the Issy-les-Moulineaux Cedex plant in France to Egypt,

Project

The client company, a pharmaceutical multinational, has always been involved in the research,
development and marketing of innovative drugs with one of the most modern and cutting-edge facilities.

The transfer of products from one country to another plays a strategic role for the Group, requiring expert management of the operation.

Developing and implementing an efficientTechnology Transfer plan, in accordance with stringent regulatory requirements, was therefore the main challenge of the S4BT Technology Transfer Team assigned to this sensitive task.

Our contribution

S4BT provided its best consultants, all with significant national and international experience, who handled:

Preliminary documentation: issuance of the Technology Transfer Strategy (TTS), Analytical Method Transfer: planning and organisation, support for obtaining samples and standards, and review of the protocol and report

Site and manufacturing preparation:

planning and organisation of manufacturing activities
review and approval of the placebo characterisation and validation protocols and reports
review and approval of the protocol
final product stability report

Quality/GMP/RA assessment:

conformity check on raw materials and products

Planning and Management:

sharing knowledge of the process
development and updating of the complete Technology Transfer Project Plan

Result

The client company achieved its stated goals, overcoming the typical international transfer problems, such as communication difficulties, the alignment of documents, regulatory differences and differences in culture, in compliance with the regulatory requirements of the process.

read about other projects

CONSULTING SERVICES ACQUIRED BY THE CLIENT COMPANY

Technology Transfer

REQUEST MORE INFORMATION

Project

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit

Digitised processes

0 k

Projects completed in 2019

CLIENT

Pharmaceutical Company

An international pharmaceutical contract manufacturer specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.

Home office

Digital Company