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13 September 2013

Regulatory Affairs

Support in drafting and managing the regulatory documents necessary to register a drug, medical device, supplement or cosmetic with the Italian Health Authorities (AIFA – Italian Medicines Agency, MDS – Italian Ministry of Health) or international authorities. The service can be fully managed both at your company or externally (turnkey).

 

Our consulting

For drugs

  • Online support or at your company
  • Feasibility studies
  • Due regulatory diligence including:
    • regulatory evaluation of the dossier that has to be acquired
    • evaluation of regulatory adjustment costs of in progress dossiers
    • market analysis of in progress dossiers
  • Drafting of CTD dossiers and their conversion to eCTD dossiers (Electronic Common Technical Document) including drafting of 3 and 2.3 forms with a signature (1.4.1) and drafting, revising/updating of 4 and 5 forms with 2.4, 2.5, 2.6, 2.7 and signatures (1.4.2 and 1.4.3)
  • Regulatory submission in Europe with MRP (Mutual Recognition Procedure), DCP (Decentralized Procedure), CP (Centralized Procedure), National Procedures for known molecules or NCEs (New Chemical Entities)
  • Drafting of ANDA (Abbreviated New Drug Application: Generic Drugs) and NDA (New Drug Application)
  • Maintenance and development of AICs (Marketing authorizations): changes according to 1234/2008/CE regulation and renewals (Italy and Europe)
  • In-depth forecast of tasks to move from your current situation to the state of art (including presentation of changes and the procedure to follow up to publication on the Gazzetta Ufficiale)delivering to the company the updated dossier
  • Planning of price strategies: drafting of documents, determination of reimbursement categories, transaction with Health Authorities both Italian and foreign
  • Validation support with Farmindustria as far as regards Scientific Information work

 

For MDs (Medical Devices)

  • Codification of Mds
  • Validation by a Notified Body (NB) selected by us and resulting notification to the Ministry of Health

 

For supplements

  • Ministry Notification
  • Technical assessment (both of the small dossier to be acquired and of the formula and printed material pertinence)

 

For cosmetics

  • Ministry Notification
  • Technical assessment
  • Support for Compliance with Cosmetics Regulations assessment

 

Various

  • Drafting of technical texts (Italian-English translations), SmPC (Summary of Product Characteristics), Pil (Patient Information leaflet), SOPs (Standard Operating Procedures), company documents
  • Assessment of regulatory compliance of the company Quality System documents
  • Sessions of specific training for personnel

 

Vigilance

  • Take on of QPPV responsibility (Qualified Person for Pharmacovigilance) local and European
  • Materiovigilance
  • Cosmetovigilance

Our consulting are ideal to answer timely and promptly to the needs of facilities which require resources that are professional, competent and expert.

 

Use cases

  • Development of a new product
  • Maintenance of your products
  • In case the Regulatory Department is virtual or underdeveloped with momentary activity peaks or lacking internal know-how
  • To obtain immediate access to the most updated information in the Regulatory, Pharmacovigilance or Quality fields
  • To carry out quickly activities that internal resources alone couldn’t fulfil. Nowadays, speed is a fundamental parameter to consider: outpacing everybody is essential

 

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