Regulatory Inquiries
We would be happy to assist you in answering and developing specific inquiries to and from authorities
Regulatory inquiries properly framed and adressed
During the application, expansion, or modification of manufacturing and wholesale permits, as well as in general pharmaceutical work routine, regulatory inquiries often arise.
We would be happy to assist you in answering these inquiries or developing specific inquiries to authorities, as well as the proper addressing for these topics.
We would be happy to assist you in answering these inquiries or developing specific inquiries to authorities, as well as the proper addressing for these topics.
Furthermore we establish an initial contact for you with representatives of the authorities (state oR federal authorities) and maintain this on your behalf in the short or long term.
Our Experts assist you with:
communication with state and/or federal authorities
- application, modification and expansion of manufacturing and wholesale permits
- regulatory inquiries in the field of drug development – scientific advice
- notifications according to § 67 AMG
preparation and assessment of CMC sections for the application of clinical studies (IMPDs, INDs)
application of laws and regulations as well as their interpretation
Our experts are available to support you in your day-to-day work with the continuous implementation of regulatory requirements, whether for a limited or unlimited period of time.
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.