Quality agreement services for life science companies

Quality agreements

With our support, you will have a quality agreement where the responsibilities are clarified from the start. This will prevent unexpected surprises and divert critical situations.

The quality agreement is the bridge between your company and the partner to ensure and document adherence to both legal requirements and your specific instructions. It is vital that the distribution of responsibilities is captured correctly to ensure that all legal obligations are ascertained and that your investment with your partner is secured.

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Quality agreement essentials

If you plan to engage in an GxP activity, the responsibilities need to be defined in a quality agreement. It must capture all legal requirements for the planned activity but also detail the criticalities for the specific activities you are planning.

It can be difficult to know if the template you have been provided reflects the actual requirements, if your obligations are correctly captured or if anything is missing. A well-written quality agreement supports the sustainability of your  business and the relationship with your partner.

Why use our support when setting up quality agreements?

Whether you need to set up a new quality agreement or to review a suggested template, our experts can assist you with our knowledge about the regulated requirements as well as practical experience.

We can also support you in the maintenance of quality agreements to make sure they are up to date according to current standards and compliant with review cycles.  

More good distribution practice (GDP) support services

Acting Responsible Person (RP), including 24/7 coverage
Auditing
Evaluation/structuring of distribution system
Quality management system (QMS)
WDA application management, including inspection support
Management of product quality complaints

Your contact person
Portrait of Nelly Fransen Arex Advisor

Nelly Fransén

www.arexadvisor.com

Arex Advisor AB

  • Sveavägen 9,
  • 111 57 Stockholm
  • Sweden

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Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.