Regulatory Affairs

Regulatory Affairs are implicated in each stage of the drug’s life cycle, and they therefore play an important role in the key departments of pharmaceutical laboratories (Pharmacovigilance, Market Access or Compliance, amongst others).  In light of this, Meisys provides comprehensive support with the added value of our vast knowledge of both the pharmaceutical industry and all stages of drug development.

In the field of Regulatory Affairs, Meisys specialises in both general consultancy and auditing tasks and also specific activities including the following:

Drafting of SOPs or adaptation to Spanish legislation.

SmPCs and package leaflets: legibility tests.

Design of printed packaging materials for drugs (labelling, cardboard, aluminium, leaflets, etc.)

Braille certificate requests.

GMP and GDP training of staff.

Expert reports for variations.

Dossiers on medical innovations of therapeutic interest.

Dossiers of full records.

Applications to the AEMPS (Spanish Agency of Medicines and Medical Devices) regarding the new registration of a permanent pharmaceutical laboratory or storehouse, including blueprints, technical specifications, naming of Technical Director, etc.

Applications in NeeS and eCTD format.