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With our blend of genuine empathy and deep industry knowledge, we find the right expert for long-term success.

  • Project Consultants are specialists in solving operational tasks within a given time frame.
  • They are highly qualified professionals from the pharmaceutical, medical technology and healthcare sectors.
  • You have many years of experience and deep technical expertise
  • Our Project Consultants work independently in the customer project
  • We offer three different types of project consulting, depending on the needs of the client.

Project Consulting

  • No headcount
  • On-site or remote use
  • Flexible project runtimes
  • Possible takeover
  • Resources available in the short term
  • Lack of expertise
  • Quality through permanent employees
  • Quality through permanent employees
  • Delegation of authority
  • Disciplinary enforcement
  • Combination of conception and operation
  • Professional interdisciplinary teams
  • Low fluctuation
  • Lower hourly rates

Confidence Beyond Compliance Ensuring your internal systems, or those of your supplier or client meet the necessary requirements, is essential before undertaking any regulatory process. It is also pertinent to follow good practice (GxP) guidelines in order to satisfy the regulators that all aspects meet their standards.

 

A functional pharmaceutical quality system is not only a regulatory requirement, but also an integral element in pharmaceutical organizations to assure products’ pharmaceutical quality and patients’ safety. A well designed and efficient quality system will serve as a safe and sound basis for your business. It documents and verifies your approach for high quality products towards health agencies.

 

We have a broad spectrum of competencies in GxP quality management as well as in adjoining regulatory areas. This approach allows us to manage interfaces even in complex situations and provide additional value especially for small- and medium-sized organizations.

GxP Services

  • Providing consultancy, gap analyses and operative support on GxP topics
  • Designing, implementing and optimizing your GxP quality system Preparing applications for manufacturing and wholesaling authorizations
  • Designing and documenting processes as SOPs
  • Implementing risk management approaches / FMEA analyses
  • Planning and performing GxP audits and self-inspections
    (incl. CAPA management)
  • Preparing and supporting health agency inspections
  • Supporting remediation activities