Our services for the Pharmaceuticals and Medical Devices industry
We support you in drafting your quality and regulatory documents, in setting up your quality system or in improving your compliance with EU and US GMP – GDP – ICH Guides – 2017 regulations 745 and 746 – 21 CFR 820 – – NF EN ISO13485 …
Examples of services:
- Preparation of inspections (ANSM, FDA, etc.)
- Supplier audits, audits of subcontractors
- Assessment of quality documentation: deviation reports and investigation tools, CAPA plan, change management, responses to customer complaints …
- Creation of quality documents: quality specifications, Quality Manual, CE marking technical files, 510k …
Cabinet Ace Performance offers various training themes that, by encouraging learning by experience and using a different pedagogical approach, resulting from coaching, assure you an undeniable competitive advantage.
Alone or in combination with a coaching service, these trainings bring you knowledge and know-how essential to the development of your company.
Here are some examples below :
- How can we set up an efficient and compliant quality organization? From know how to expertise
- Qualification process of investigators
- Medical Devices Regulations
- Soon inspected by the FDA? : 2 days to prepare yourself !
- Equipment qualification and process validation
- GMP applied to Quality Control Laboratory
Design and Marketing of Medical Devices
We support you from the Design to the Marketing of your Medical Devices thanks to our expertise in the following areas:
- Choice of materials and technology
- Design assistance and deployment of design tools (AMDEC, Value Analysis, Work Factor)
- Patent filing and industrialization
- Production of kits for the Pharmaceutical Industry
- Project monitoring, technical expertise for development and production, Lean Manufacturing