Regolatory

In relation to the marketing authorisation phase, for the post marketing of human, veterinary, homeopathic and cosmetic products, as well as for medical devices, dietary products and supplements, we elaborate and identify the most suitable regulatory strategy for the purpose.
We pay particular attention to the implementation of digitalization and computerization processes.
We supply highly-specialized staffing to satisfy any temporary company needs or to carry out activities that require specific know-how.

  • Regulatory strategy
  • Regulatory due diligence – regulatory assessment of dossiers to be acquired; – assessments of the costs of regulatory
    compliance of the dossiers acquired; – market analysis of the dossiers acquired;
  • Preparation of CTD dossiers and their conversion into eCTD (Electronic Common Technical Documents), which includes the preparation of Modules 3 and 2.3 with
    signature (1.4.1) and the preparation, review/updating of Modules 4 and 5 with 2.4, 2.5, 2.6, 2.7 and signatures (1.4.2 and 1.4.3);
  • Regulatory submission (presentation to the regulatory authorities) in Europe with MRP (Mutual Recognition Procedure), DCP (Decentralised Procedure), CP (Centralised Procedure), National procedures for known molecules or NCEs (New Chemical Entities);
  • Preparation of ANDA (Abbreviated New Drug Applications: Generic Drugs:) and NDA (New Drug Applications);
  • Maintenance and development of MAs (Marketing Authorisations): variations in accordance with Regulation 1234/2008/EC and Renewals (Italy and Europe);
  • In-depth estimation of the activities necessary to switch from your current state to the state of the art (including the submission of variations and the procedure to be followed through to publication in the Gazzetta ufficiale – Official Journal), delivering the updated dossier to the company;
  • Elaboration of price strategies: preparation of documentation, determination of reimbursement class, negotiation with Italian and overseas health authorities;
  • Support for accreditation with Farmindustria for medical sales activities;
  • Elaboration of technical texts (IT<->ING translations), SMPC (Summary of Product Characteristics), PIL (Patient Information leaflet), SOPs (Standard Operating Procedures), corporate documentation;
  • Verification of the regulatory compliance of the company’s Quality System;
  • Personnel training.
  • Classification of medical devices;
  • Certification with recognized certifying authority (NB – Notified Body) and notification to the Ministry of Health.
  • Ministerial notifications;
  • Certification with recognized certifying authority (NB – Notified Body) and notification to the Ministry of Health.
  • PIFs and notifications
  • Laboratory tests
  • Safety assessments
  • Technical assessments;
  • Support for checking compliance with the Cosmetics Regulation
  • Support with goods stuck at customs
  • Development of packaging material artwork
  • Product information leaflet
  • Readability test
  • Certified Italian/other language translations
  • Production and review of promotional material artwork (Visuals, Brochures, leaflets, technical data sheets)
  • Biocides
  • Reach
  • CLP

• Global management of the Pharmacovigilance service, pharmacovigilance quality, consultancy for re.engineering
• Preparation for regulatory inspections (mock inspections), Due Diligence investigations and Third Party audits, Audits on Service Providers and
Affiliates, internal Audits, Data or documentary audits
• Preparation and review of procedural systems
• Support for safety disputes
• Training and courses for sales representatives
• PV Quality Assurance Outsourcing and EU-QPPV Outsourcing
• CAPA, PSMF, SDEA, PSUR, DSUR, RMP
• Data Integrity and Compliance Assessments, Computer System Validation, Data Migration plan and Data Quality Control
• E-Learning Content development
• Gap Analysis of the Quality System vs EU GVP
• Remote Data Entry support
• Aggregate Safety Report Prep and Submission;
• Eudravigilance and XEVMPD, Case processing “ICSRs” and screening literature
• Signal Detection
• PV Local Contact point
• Translations
• Specific local requirements
• Training