Manufacturing and wholesale licenses as well as BTM
We support you in obtaining and maintaining licenses as well as their modification or extension – moreover in certifications in the GMP and GDP area.
Be on the safe side with Regulatory Complinece
require permission from the competent authority (§ 13 AMG).
Those who engage in wholesale of medicinal products within the meaning of § 2 paragraph 1 or paragraph 2 number 1 AMG, Testsera or Testantigens, require permission (§ 52a AMG).
In addition, active substance traders need to register as well as the trade with narcotic drugs and preparations also requires a permit under the narcotics law.
We support you on the basis of a comprehensive GAP analysis in obtaining and maintaining permits (manufacturing license, wholesale license, narcotics license) – as well as in their modification or expansion and also in certifications (GMP, GDP).
Our Experts assist you with:
inspection readiness activities
- execution of mock inspections
- processing of corrective and preventive actions (CAPA)
- train your employees
Our support
Do you need support or have questions?
Our team is at your disposal and will be happy to advise you on topics related to quality management systems, analyses, certifications, and regulatory issues.
Free initial consultation
Analysis & planning
Implementation & Training
From planning to execution
How we work
Our processes are precisely coordinated with each other, ensuring a smooth implementation process. We will guide you step by step through all relevant topics and provide you with individual and comprehensive advice.