Pharma QA

Key2Compliance offers quality management and quality assurance in the pharmaceutical industry. We help companies of all sizes achieve efficient quality management in different phases and aspects of the product life cycle.

We provide services and training related to GCP, GVP, GMP, GDP and GLP to ensure that you can fulfil all complex regulatory requirements regardless of your geographical ambitions. Our dedicated professionals have extensive industry experience combined with the ability to understand your business needs. In this way we help you to ensure the quality of your products and compliance with GXP requirements using the right people, in the right place, at the right time.

We make complex things easier.

Pharma Quality Assurance

Key2Compliance® supports you with:

  • Audits and inspections                                         
  • Inspection readyness
  • GAP-analysis
  • Design of QMS and quality processes
  • Implementation of eQMS
  • Trainings
  • Coaching and expert advice
  • Part-time QA-manager
  • Validation support
  • Project QA-support

We make complex things easier, for the sake of the patients

History has taught us that quality in every step of the pharmaceutical product lifecycle is necessary to ensure efficient and safe products for the end-user. No matter what type of stakeholder you are in the pharmaceutical industry, you must comply with the regulatory requirements and guidelines applicable to your business. 

To interpret and implement these often-complex directives, regulations and guidelines is not an easy task.It is critical that your Quality Management is fit for purpose and effective. This is the key to both compliance and long-term success. 

Key2Compliance offers you quality management support in all GxP areas; GCP, GVP, GMP, GLP and GDP, from setting up quality systems and processes to performing quality assurance activities and advising on quality matters. We will help you ensure the quality of your products and compliance with the requirements. 

Our solutions will be adapted to your specific needs. Our consultants have extensive experience in helping companies of different sizes, types and in different stages with a large range of services. 

Please do not hesitate to contact us for a discussion about what we can do for you!

Quality management pays off in the long run

  • Increases internal efficiency, you do not have to reinvent the wheel
  • Enables structured work and facilitates improvements
  • Creates trust from customers, suppliers, and employees, which in turn improves profitability
  • Is a visible proof that the company works in a structured way with quality issues
  • Knowledge is not linked to specific individuals and therefore always maintained within the company
  • Established information flows reduce the risk of extra work and missing those important tasks
  • Identifies problems quickly and decisions can be made on well-founded information

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