• Laboratory
  • Quality control

Quality control

Batch release

We hold a manufacturing authorisation according to section 13, paragraph 1, of the German Drug Law (AMG) for the release of drug products and conduct analytical testing for the batch release and EU release of active ingredients and finished products in our GMP- and FDA-certified lab.

 

Stability testing

We offer stability tests for finished medicinal products and active ingredients in accordance with the valid guidelines in the European and international environment.

From first clinical phase to on-going or follow-up stability of authorised medicinal products, we provide you with tailor-made solutions according to your requirements.

Our range of services

Stability studies

Our team develops matrixing and bracketing designs to efficiently conduct stability studies. We understand that each project is unique and adapt our methods accordingly. We perform in-use stability and photostability studies. We advise on stability concepts and runtime specifications in product development and lifecycle management.

Stability storage

Your samples are in safe hands with us. We offer GMP-compliant storage at various temperatures and humidity conditions, including

  • 25 °C / 60 % relative humidity,
  • 30 °C / 65 % relative humidity,
  • 30 °C / 75 % relative humidity,
  • 40 °C / 75 % relative humidity,
  • 2-8 °C ,
  • as well as deep-freeze storage from -18 °C up to -80 °C.

If you require special climate conditions, we will be happy to implement them according to your specifications. Our climate chambers and cabinets are monitored 24/7 in compliance with GMP.

Stability management

We have many years of experience in conducting stability studies and take over the entire stability management for you. This includes the preparation of result reports, assessments and tabular and graphical evaluations. If required, we can enter the results directly into your templates and/or CTD modules.

Quality management

For more than 30 years, we have been conducting stability studies of medicinal products under GMP conditions and in compliance with ICH guidelines. Our service ranges from the first clinical phase to the ongoing monitoring of authorised medicinal products. Our climate chambers are equipped with state-of-the-art technology.

Logistics and distribution

We have extensive capacity in our climate chambers to store even large registration stabilities, if necessary at short notice. We carry out the logistical handling and distribution of your samples with qualified logistics companies.

Contact us. We’re happy to help!

Christiane Wiegand
Quality Control

Phone: +49 7272 7767-2521
Email:

Dr. Sandra Hürtgen
Analytical Development

Phone: +49 7272 7767-2571
Email:

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email:

Hotline

Monday - Friday

+49 7272 7767-0