Onsite Execution in the Field of GMP for Quality Assurance in the Life Sciences

As a GMP service provider, gempex offers consulting and implementation of GMP requirements as well as longer-term support in pharmaceutical/biotechnological quality assurance at the customer's site. Are peak loads occurring? Does a personnel bottleneck need to be covered at short notice? Sabbatical or parental leave replacements cannot be filled internally?
Through the flexible and immediate availability of qualified and trained employees, gempex ensures ongoing production and provides up-to-date GMP know-how. GMP compliance and product quality are maintained.

Established GMP Know-How and Competence in Quality Assurance

With 20 years of experience in onsite support, gempex knows what it takes. The team can provide support for all quality assurance tasks, e.g. for

GMP-Experienced Employees and Quick Response Time

The entire selection process of potential candidates usually has to go very quickly. Due to its own project work, gempex knows exactly which qualification profiles are required and which skills the employee must bring with it. Individual training and regular interaction with in-house GMP experts provide a good basis for supporting the customer in its balance between cost-effectiveness and quality requirements. And through the strategic combination of compliance consultancy, project management and onsite execution, the customer not only gets manpower but also up-to-date GMP know-how on top.

Selection of Reference Projects

Bayer AG
GMP consultancy and qualification for large-scale biotech plant project (German language)

Boehringer Ingelheim GmbH & Co. KG
For many years, support in the areas of pharmaceutical manufacturing with tasks and routine activities related to GMP, as well as qualification work in the project to expand the production capacity of the Respimat inhalation device (German language)

CureVac
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Continuous, broad technical support in various projects as GMP expert and project manager, quality control, project management, qualification, validation and routine GMP operation

Merck KGaA
Long-term support of different departments of the liquid and solid production in the field of GMP (German language)

Benefits

  • Covering peak workloads or personnel bottlenecks
  • Ensuring routine production and GMP compliance
  • Short-term deployment and flexibility in assignment period and location
  • Access to GMP experts in the gempex back office
  • Forms of support: Contract for work and services, service contract, employee leasing