Reliable information is essential for the success of a company.
Christoph Kolumbus
Approval and registration of medicinal products is one of the core tasks of the regulatory authorities. After the granting of a marketing authorisation for a medicine, the marketing authorisation holder shall notify the competent authorities of any change. Major changes may only be implemented after approval by the regulatory authority.
Are you planning a concrete project in the field of drug approval? We are happy to help you with the implementation!
We offer the following services to support you with your project:
Consulting
Each project starts with a consultation. You tell us what you intend to do – we will advise you on whether, how and in what time frame the project can be implemented. We will find a common, consensus-based solution.
Variations
What are variations?
Variations are
- administrative changes, e.g. a change of company name, address, or a new product name (e.g. after a marketing authorisation transfer)
- changes to the characteristics of a product that can affect its quality, such as a change to its composition, CEP updates (Certificate of suitability), changes in the supply chain, packaging, or test methods
- changes to the safety, efficacy or pharmacovigilance of the product, e.g. inclusion of new text due to requests from the competent authority or new safety information.
Variations are sent to the competent authority through the Common European Submission Portal (CESP) which provides a secure method of communication with regulatory agencies. We can organise your setup to the CESP system and manage the whole submission procedure. Thanks to this electronic system it is easier to handle the variations for a product.
How long does it take until variations are approved?
It depends on the complexity of the change. For some administrative changes, there is no waiting time and you are allowed to implement the change immediately. For more complicated changes, especially those to the composition or manufacturing process of the product, approval procedures may easily take 6 -9 months. We can support you with the preparation and submission so that you are able to submit a variation that will be accepted easily by the authorities.
Adaptation of product information
We will be happy to adapt all product-related texts for you in the event of changes. We revise technical information, instructions for use and labelling texts and bring them into the correct format. We can help you with text changes according to your ideas or due to governmental requirements.
Dossier update
We offer you a formal and professional examination of your marketing authorisation documents and adapt them, e.g. according to your changes in manufacturing or after new regulatory requirements. By staying in direct contact with you, we will always keep you up to date.
eCTD/CTD
We convert your drug dossiers into CTD format and provide you with an eCTD structure on request.
And everything else…
We are constantly expanding our portfolio in order to offer a suitable solution for all our customers. If you have not been able to place your project in any of the other areas, please contact us directly. We meet the challenge!
If you have any questions, please contact our regulatory affairs team here. We will be happy to implement your project!
Dr. Christiane Fenske
Dr. Tao Tang
This post is also available in: German