Standardization And Quality

Standardization is vital in creating and sustaining quality.
Quality is the extent to which a user’s needs and expectations are met.

Our experts can assist you with audit preparation to obtain certification in the following topics:

  • ISO 9001 – 14001
    • Quality management system – Environmental management system
  • ISO 13485
    • Quality management system for the design and manufacture of medical devices
  • GDP (Europe)
    • These guidelines establish appropriate tools to assist wholesale distributors in carrying out their activities and to prevent falsified medicinal products from entering the legal supply chain.
    • The Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) is a globally consistent, recognized and standardized certification for pharma shipments in air freight.
  • Others on demand

How are you going to achieve the desired certification?

In concrete terms, our skilled and experienced team can support you to obtain the certification by on-site assessment of your quality management system and the resources implemented in your company. They will support and advise you in the modifications and improvements to be made. Facilities and materials used will also be part of the review.

These steps will ensure that you are well prepared for the audit that the certifier body will then carry out to determine whether you will obtain the certification. Our dedicated team will support you until the end of the process.

Regulatory And Compliance

Are you planning to extend your activities in new countries or regions?

  • We offer you a guidance through the steps to obtain quality compliance and we validate your processes.


Regulatory environment is becoming more and more stringent for companies operating in the healthcare and Life Sciences industry. Our experts can help you to measure the various ways regulations affect your products so that you are in a position to make the right decisions for your business operations.
We will guide you through the steps involved in obtaining regulatory approval to sell your products in regions where you are not operating.
We also anticipate changes and align supply chain strategies or investments in order to remain compliant.