Pharmaceuticals – Registration dossiers in eCTD

Pharmaceutical products (also called drugs, medicines, or medicinal products) are used to diagnose, cure, treat, or prevent diseases by means of a pharmacological way of action. Pharmaceutical products in Europe must comply with the European Directive 2001/83/EG. The registration of pharmaceutical products can usually be done via national or MRP/DCP procedures. After finalization of a registration procedure the pharmaceutical dossier must be maintained and kept up-to-date according to the applicable rules.


Regulatory documentation and services for pharmaceuticals

YES Pharma Consultancy B.V. has compiled various parts of registration files for drugs. For example Chemical/Manufacturing/Control dossiers (CMC) usually Module 2.3 and Module 3 have been written according to the requirements of the ICH guidelines and Pharmacopoeias.

On request of our clients we perform GAP-analysis procedures and compare the production protocols with the current registration dossier. If necessary, we compile or update the CMC dossier assuring compliance with the manufacturing protocols. We can also prepare the variation packages and submit them to the authorities.

Moreover, we have prepared toxicological and (non) clinical overviews and summaries (Module 2.4)  and we are specialized in writing Expert Reports (Module 2.5) considering a change in delivery status (Rx to OTC). SPC’s, patient information leaflets, and packaging texts were prepared as well. In addition we prepared variation packages for existing marketing authorizations in eCTD format.

Thus, various modules of registration files can be compiled and published in eCTD. Afterwards submission in CESP can be done. The submission of complete Marketing Authorisation Applications or variation packages to regulatory authorities and follow-up belongs to our services.