Your Quality Partner

Your Quality Partner

QUALITY MANAGER FUNCTIONS

We can exercise the functions of a Quality Manager on a part-time basis, ensuring that we provide support to clients in Quality matters, as well as ensuring that the continuous improvement process is maintained.

Contact

QUALITY STANDARDS IMPLEMENTATION AND MAINTENANCE

GMPs (GOOD MANUFACTURING PRACTICES)
We will make sure to apply the Good Manufacturing Practices or GMPs to your manufacturing operations. Either if it is a pharmaceutical manufacturer, an active compounds manufacturer or a supplier, respecting the GMPs will provide you additional value to your company at the eyes of your customers and health authorities. We take into account both the European GMPs as well as the ICHs.
GDPs (GOOD DISTRIBUTION PRACTICES)
We can help you implement and maintain the Good Distribution Practices or GDPs in your distribution operations, both for pharmaceutical products as well as for the raw materials for its production. Respecting the GDPs might add an extra value at the eyes of your customers and health authorities which require high standards of safety and traceability.
ISO 13485. QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES
We can help you meet the requirements needed to get a quality management system which will enable you to demonstrate your capability to provide medical devices and related services which will meet the reglementary requisites applicable and those of your customer. This service might be useful for all those organizations which are involved in one or more steps of the product life cycle, including the design and development, production, storage and distribution, installation or service of a medical device and design and development or provision of related activities.
ISO 11137-1. RADIATION STERILIZATION OF HEALTH CARE PRODUCTS
We can help you developing, validating, and controlling a radiation sterilization process of a sanitary product or a product destined to produce sterile APIs or pharmaceuticals.
ISO 9001. QUALITY MANAGEMENT SYSTEMS
We can implement and maintain your Quality Management System, based in a continuous improvement system, which, properly integrated, will improve the efficiency of your day-to-day operations, increase the overall satisfaction of your customers and keep the competitiveness of your business.
ISO 14001. ENVIRONMENTAL MANAGEMENT SYSTEMS
Implementing the ISO 14001 will allow you to optimize the resources involved in your operations, avoiding or reducing the overall waste. This cost reduction might help you keep your business competitivity and to minimize the costs overruns caused by the increasing prices of raw materials.
Contact

AUDITS

SUPPLIER AUDITS

We carry out the supplier audits required by your Quality Management System in any country. Also, we can carry them out for a whole group of customers at the same time to reduce the cost of it for each client.

  • SHARED AUDITS
    We help you to find other customers interested in the same Audit as you to reduce the costs of the overall Audit.

CMOs AUDITS

We can help you to ensure that you CMOs are producing following the current legislation.

Contact

DATA INTEGRITY

Data integrity consists of ensuring the quality of documentation related to pharmaceutical products and guaranteeing the integrity of the data that is generated and that is considered critical, both in paper and electronic format.

The warning letters issued by the FDA, after several inspections in Indian laboratories, are a sign/prove that the health authorities keep their focus in this topic.

We can carry out audits to detect week spots related to your data integrity and training your employees/staff in the huge importance that keeping a good and reliable documentation which follows the existing legislations may be beneficial when facing future sanitary/health audits.

Contact

HAZARD ANALISYS CRITICAL CONTROL POINT (HACCP)

The HACCP system can be applied to the whole food supply chain. To implement this system, a multidisciplinary approach might be necessary, involving agronomists, veterinarians, production staff, microbiologists, pharmaceutical and public health experts, food technicians, environmental health experts, chemists and engineers, depending on the study. The implementation of an HACCP system is compatible with the application of Quality Management Systems such as the ISO 9001 simultaneously.

Contact

This website uses cookies

We use our own and third-party cookies for exclusively technical purposes. Click HERE, for more information about the Cookies policy