Regulatory documentation for Pharmaceuticals:

YES Pharma Consultancy B.V. has compiled various parts of registration files for drugs. For example chemical/pharmaceutical dossiers have been written meeting the requirements of the ICH guidelines. 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 chemical/pharmaceutical dossier assuring compliance with the manufacturing protocols. Moreover, we have prepared toxicological and (non) clinical overviews and summaries and we are specialized in writing Expert Reports considering a change in delivery status (Rx to OTC). Periodic Safety Update Reports (PSURs), SPC’s, patient information leaflets, and packaging texts were prepared as well. In addition we prepared variation packages for existing marketing authorizations. YES developed an electronic tool suitable for the conversion of registration dossiers (based on word-documents) into Non-eCTD electronic Submission (NEES) format. Thus, all types of registration files can be prepared in, or transferred to NEES. The submission of complete registration files or variation packages to regulatory authorities and follow-up belongs to our services as well.

Product development:

YES provides advice in product development. We assess product suitability for the Dutch market, followed by advice on the regulatory strategy. We cooperate with formulation technologists, manufacturers, analytic laboratories, and distributors.