Regulatory Affairs
Expert and personalized support in the following areas:
We help manufacturers of active ingredients to prepare their registration dossiers both to send to the EdQM (CEP) and directly to manufacturers of finished products (ASMF). We also prepare ASMFs for all types of raw materials.
We support both during the evaluation of the documentation resolving the deficiencies of the authorities and for the maintenance of the dossier throughout the life of the product.
Support in the preparation of different types of dossiers (innovative, generic, bibliographic, medicinal plants ...) for medicines for human and veterinary use.
Our support also includes monitoring during the evaluation process and the resolution of deficiencies. Realization of the readability tests, price request, National Code... and other regulatory requirements.
- Preparation, presentation and monitoring of variations type IA, IAIN, IB or II, grouping of variations, `worksharing´…, as well as transfers of ownership in Spain and other state members, in format.
- Preparation and submission of documentation in e-CTD format
- European Dictionary
- Temporary suspensions and revocation.
- Review of promotional materials
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