Regulatory Affairs

Qualipharma - Regulatory Affairs

Expert and personalized support in the following areas:

Regulatory strategy

We analyze each project in a personalized way in order to provide each client the regulatory support they need in their projects.

The regulatory strategy is the key for the development of the pharmaceutical products, therefore a good strategy is a guaranteed victory when registering a dossier.

CEPs and ASMFs preparation

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.

Preparation of the Dossier´s documentation of the finished 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.

Authorization requests for the different types of procedures and other formalities with the health authorities

  • Centralized procedures (PC)
  • Decentralized procedures (PDC) and Mutual Recognition (PRM).
  • Including national phases
  • FDA projects (IND, NDA, BLA, ANDA)

Post-authorization maintenance

  • 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

Audits and dossiers compiling

Before buying and selling a dossier or to update the documentation of old dossiers.

Review of legislative changes

From Qualipharma RA & MD we keep our clients up to date with legislative developments that affect different types of medicines.

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