Regulatory Affairs

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Medicinal Products

Registration of Medicinal Products in EU

Regulatory, strategic and operational support in all steps of the registration both with National Procedure and with European Procedures.

Pre-Authorisation Activities
  • Examination of the current legal framework for a rational development of the product;
  • Strategic advice on the PK/Phase I/Bioequivalence studies and subsequent conduction of clinical studies;
  • Support to find a partner for chemical and pharmaceutical development, analytical, stability tests, bioequivalence study, etc.;
  • Identification of the appropriate legal basis for the registration;
  • Gap analysis on module 3-4-5 of preexisting registration dossier;
  • Preparation, review and evaluation of 648/1996 application;
  • For European Procedures also the choice of the Reference Member State;
  • Pre-submission meeting with competent authorities;
  • Submission of the request and supporting documentation for a Scientific Advice;
  • Preparation, editing or review of the registration dossier (modules 1-5 in CTD or e-CTD format);
  • Preparation of specific documentation in accordance to national requirements;
  • Evaluation of the registration dossier to be submitted and compliance for the check in phase (validation and start-up of the procedure).
Submission and validation phase
  • Submission of registration application to the Competent Authorities and maintaining contacts with local Competent Authorities;
  • Preparation of response documents to the Authorities in case of Deficiency Letter or further documentation request.
Management of the National Phase for European Procedures
  • Preparation, review and submission of the End of Procedure Proposed National texts;
  • Support for access to the national market strategies and Price and Reimbursement Procedures;
  • Support up to MA granting.
GB Pharma offers support for all regulatory activities for the MA maintaining through the entire life-cycle of the medicinal product, both with back office mode and in house:

  • Preparation, review and submission of administrative, quality and safety variations;
  • Line-extension applications;
  • Preparation, review and submission of Renewal Applications;
  • Preparation and review of Quality, Non-clinical and Clinical Overview for Variations and Renewals;
  • Gap-analysis for the alignment of obsolete dossier according to current requirements;
  • Updating of the texts according to Core Company Data Sheet
  • Conversion of dossier in NtA98 or prior format into CTD or e-CTD.
  • Supply of pharmaceutical bollini services;
  • GB Pharma provides insertion and updating of the product information in the database Farmastampati;

Regulatory support in Extra-EU Countries

  • Support for the registration and maintenance of medicinal products in Extra-EU Countries (e.g. Middle East, North-Central and South America, Asia, Africa, etc.), in accordance to local procedures and requirements.
  • Development of the registration dossier and support during all registration process phases, also with co-operation with local agents.