Virtual Classroom Training – Approach to Conducting Efficient Audits
Need some practical advice on how to conduct effective audits?
You innovate. We navigate.
Established in 2006, we help teams navigate highly regulated areas of pharma and biopharma. Whether you’re looking for support with GMP, Quality Management, Drug Regulatory Affairs or eCTD submissions, our team of experts will help you achieve your goals in a timely and efficient manner.
The eCTD allows applicants to electronically submit scientific-technical information required for regulatory procedures (e.g. marketing authorisation or variation applications) to the regulatory authorities.
Electronic submissions are complex projects. They require appropriate IT infrastructure, digital literacy of the team, standardised data management and workflow.
We are specialists in the preparation and submission of eCTDs and offer everything you need for a smooth and successful eCTD submission.
Have a question or need assistance? We welcome you to contact us.
Innovative ways of transferring knowledge and keeping
up with regulatory changes are needed in today’s working environment. Using digital media enables interactive learning anywhere, anytime. We have developed a range of fee-based e-learning courses for our corporate clients. Can’t find the course you are looking for? We would be happy to create a tailor-made e-learning course for you. Please contact us for a customized quote.
Regulatory processes in the pharmaceutical sector are becoming increasingly digital. This process will impact traditional workflows and require additional skills from industry and regulatory personnel. There are many factors to consider and requirements to meet. Data management is of particular importance. We look forward to working with you to plan your route. Contact us to discuss.
Dr. rer. nat. Barbara Jentges
Senior Expert Drug Regulatory Affairs & e-Submissions, CEO
“As an experienced Drug Regulatory Affairs specialist, I am aware how company internal processes should be coordinated best in order to achieve marketing approval of a complex product. It is important that all employees, from the management down to the experts, act together.”
Dr. rer. nat. Lothar Hartmann
Expert for Quality Management & GMP, CEO
„Due to my extensive experience working in international companies, at operational level as well as on global level, I am aware of the requirements and expectations towards Pharmaceutical Quality Systems and GMP. My advice is pragmatic and focused.”
Pharmaceutical Legislation of the European Union, Japan and the United States of America – An Overview, Updated and Expanded Second Edition
Written by experts, this book helps you understand how the US, Japan and the EU regulate pharmaceuticals.
SPOR – EMA’s Concept to Implement ISO IDMP Standards<br>
SPOR" - does that remind you of your Latin lessons and "SPQR"? Notice the difference - the little hook that turns the 'O' into a 'Q' ....
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