Services (D, E, F)

Consulting
We show you how to ensure an optimal GMP/GDP status in your company and how to maintain a proper quality assurance system.

Professional support
We support you on short notice and in an uncomplicated way with GMP/GDP problems, and connect you to further professional or legal support. 
We help you to establish and maintain your quality assurance system as well as to create the Site Master File.
We also actively assist you in creating GMP concepts, risk analyses and topics such as validation/qualification and CSV.

Audits
We support you when you perform your own audits, or by evaluating audits from third parties, or by carrying out audits for you.
We offer support for qualifying suppliers, manufacturers and laboratories, as well as in preparing for official inspections or client audits.

Training
With tailor-made and on-site training, we show you how to simplify and improve your quality assurance system as well as how to institute GMP action plans.

Regulatory Affairs
We advise you in admission issues and work closely with competent partners who are active in the field of eCTD creation.