Design, implementation and maintenance of Quality Systems according to the regulatory requirements of the products (GMP, GDP, ISO13485, HACCP…).
Regulatory
Quality Management Systems (QMS) Services
Ensuring product quality and regulatory compliance is critical to success in industries like pharmaceuticals, biotechnology, medical devices, among others and will improve the position of your product. Our Quality Management System (QMS) services are designed to help you design, implement, and maintain a robust quality system that meets the highest regulatory standards, ensuring both compliance and operational excellence.
We identify your needs and help you establish a QMS tailored to the regulatory requirements of your specific product: GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), ISO 13485 for medical devices, ISO 9001 for general quality management, or HACCP for food safety.


Revision and writing of quality objectives, quality policy, quality manual.

Revision, drafting and implementation of the necessary working procedures.

General and specific training on industry standards (such as GMP, ISO, or HACCP) or on specific internal procedures and operational practices (CAPA, Complaints, Change Control, Non-Conformity…)

Support for audits (suppliers, third parties/partners), revision and writing of technical agreements.

Support and assistance with certification audits, inspections by competent authorities and notified bodies, etc.

Support in the risk management process: risk identification, risk analyses, risk evaluation, risk control.

Support for validations/verifications