Analytics for Medicinal Products & Co.

The pharmaceutical laboratory of Diapharm provides fast and straightforward analytical support for manufacturers and contract manufacturers. On demand release examinations are certified by a Qualified Person (QP).

Analytics  
analytical consulting
  
method development  
  
validation of methods  
project  analytics  
stability testing  
certified release testing   
  
quality control    

Medical devices, food supplements, cosmetics or medicinal products of chemical or biological origin: We offer targeted and economic solutions for the analysis and quality control of a broad variety of products. Our focus of competence and performance lies on: 

In addition to that the analytical laboratory of Diapharm possesses a manufacturing license for batch release according to Section 13 sub-section 1 of the German Drug Law. The Qualified Person (QP) of our laboratory assumes responsibility and testifies release tests – including tests for starting materials and bulk ware procured from inside or outside the European Union. With this, Diapharm simplifies matters for marketing authorisation holders: According to Annex 16 of the EU GMP Guideline the client's QP can refer to QP certificates from us which guarantee some relief for the performance of releasing medicinal products for marketing. 

However, the laboratory services of Diapharm start at a much earlier stage, i.e. with analytical consulting which takes into account national and international requirements and which develops target-optimised analytics for each product. From the pilot batch up to long-term stability - our pharmaceutical laboratory offers individualised single services as well as complete outsourcing or project management for the analysis of medicinal products and related products.


 
DiapharmGruppe - DiapharmGruppe

   Strategic Advice
   Portofolio Management
   Regulatory Affairs
   Medical Affairs
   Clinical Management
   Pharmacovigilance
   Audits & Inspections
   Quality Services & Release
   Analytics

Related news
Conference: Stability Testing for Pharmaceuticals, 25. - 26.11.2008 >