Compliance in the field of life science
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Sara Sjögren
Division Manager, Engineering & Digital Services
+46 (0)736 84 05 37
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Compliance in the field of life science.

The global life science industry is approaching revenues of USD 1500 billion. Companies are battling to meet industry regulations while also continuing to drive innovation and develop new products.

Legislation and governance

Compliance involves following the rules as all companies in the life science sector have to do in order to guarantee that the products emerging onto the market (such as medical products and medications) are safe for people to use.  Demands for compliance in life science have increased over the last few years and are expected to grow further in the future. Thus meeting business targets in accordance with strict government recommendations presents a major challenge, particularly in an industry where non-compliance could constitute a threat to patient health and safety. Life science companies therefore need to understand the complex regulations and integrate them in their day-to-day procedures.

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Corporate transparency in all respects

Failure to comply with legislation and regulations could result in fines, plus the even more costly element of adverse publicity and damage to reputation. Therefore, companies should always make sure they work proactively and are prepared for regular inspections. Involving the supervisory authorities right from the time of the innovation process is another way of applying corporate transparency in all respects. Approval from the authorities is an important step towards ensuring the long-term health of the company.

Compliance in the soul of the company

It is important for life science companies to apply transparent working methods, ensuring that internal processes and documents are always ready to be viewed and meeting demands from the ICH, FDA and ISO, for example, along with the GDPR and other issues relating to personal data and privacy. Encouraging, and even rewarding an ethical approach can also streamline compliance with regulatory requirements. Making ethics and privacy part of the company’s DNA has proven to be a crucial success factor in Life Science and biotechnology.

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