The pharmaceutical industry is recognized worldwide by the narrow quality standards by which it is governed, whether mandatory requirements as imposed by international or national law, whether by guidelines drawn up and implemented by various Quality organizations.
Compliance with these requirements is a critical step for any company wishing to enter this market.
In order to help our clients, PHAGECON offers a portfolio of services in this area that can cover all areas and needs, from the preparation of documentation to the liaison with the authorities to obtain the most various certifications.
Licensing of Entities
- Manufacturers of Medicinal Products for Human Use
- Manufacturers of Medical Devices
- Manufacturers of Medicinal Products for Veterinary Use
- Wholesale Distributors of Medicinal Products
- Wholesale Distributors of Medical Devices
- Wholesale Distributors of Medicinal Products for Veterinary Use
Preparation, submission and support during the all process
Qualified Person (QP, Technical Director or Technical Responsible) Service
Quality Management Systems (QMS)
Conception and implementation of a Quality Management System in accordance with the several standards and legislation in force for the several segments.
- Manufacturers of Medicinal Products for Human Use
- Manufacturers of Medical Devices
- Manufacturers of Medicinal Products for Veterinary Use
- Wholesale Distributors of Medicinal Products
- Wholesale Distributors of Medical Devices
- Wholesale Distributors of Medicinal Products for Veterinary Use
Preparation, submission and support during the all process
Qualified Person (QP, Technical Director or Technical Responsible) Service
Training
- Good Distribution Practices
- Good Manufacturing Practices
- ISO 9001:2015
- ISO 13485:2016
- Medical Devices
- Cosmetics
- Food Supplements
Medical Devices
- Preparation and revision of the technical documentation;
- Registration/notification of medical devices;
- Support in the process for obtaining EC marking
Food Supplements
- Preparation and revision of the technical documentation;
- Notification and Registration
Biocides
- Preparation and revision of the technical documentation;
- Notification and Registration