Compliance

Never worry about complex regulatory and quality requirements again.

Compliance is the act of adhering to regulatory requirements imposed by the government and internal stakeholders, among others. Start-ups and established companies in the life sciences and medical device & digital health sectors in particular have to comply with a vast number of regulations when developing products and services. Not all organisations in these sectors have knowledge of and experience with these rules and requirements. Understandably, they prefer to spend their time and energy on developing their products and services, and in case of a go-to-market, processes that are already time-consuming enough.

Technology and compliance as a whole

As part of our Compliance business proposition, we handle everything related to regulations and quality requirements. We consider technology and compliance as a whole and take full responsibility for this. You only have to deal with one party, which means clear, short lines and as result, time and cost savings. We realise that speed is of great importance, especially in case of a go-to-market plan. While you focus on your product and processes, we take care of compliance and ensure continuity of quality and competencies across the many sub-specialisms.

Added value of compliance

  • Expertise: we have knowledge and expertise in all areas: regulatory affairs, quality, qualification and validation throughout the value chain (from registration to end-of-life).
  • Efficiency: we combine technology and compliance as a whole. This results in greater efficiency, time and cost savings, and clear, short lines.
  • Knowledge protection: continuity in terms of competencies and knowledge related to sub-specialisms.
  • Acceleration: you are more agile, which enables you to improve your market position and margins.

Client case study – Successful, ongoing audit support at Ablynx

Ablynx is a young company that develops next-generation biological drugs. Ordina helped Ablynx pass a number of major audits and will continue to ensure that the company complies with regulatory and quality requirements throughout the various stages of the process in a timely manner. Read more about this case study here.

In Ordina, Ablynx found the knowledge and expertise it lacked internally, and thanks to Ordina, now has a sound knowledge of all validation processes and the ability to implement them easily.

Our approach

Compliance is a niche market, in which just a few local players operate. Among them, Ordina and we are one of the only companies specialised in both IT and Compliance. We have the people and resources to handle anything related to statutory and regulatory requirements for businesses active in the life sciences and medical device & digital health sectors. We do this across the whole value chain of your company, from registration to end-of-life and every stage in between. Thanks to our team of over 150 people and more than 70 specialisms, we have expertise in all areas: regulatory affairs, quality, qualification and validation.

We help our clients with Compliance through the following three services:

  • Computer system validation
  • Qualification of laboratory instruments
  • Support with facilities, production and processes