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Regulatory Affairs

Regulatory Affairs

Accelerated by the situation in the Pharma Industry​, a regulatory strategy and a well-defined plan are now more than ever essential to obtain the authorization to modify a product and put it on the market as quickly as possible.

At Azierta, we are specialists in Regulatory Affairs with Global turnkey solutions​, including Ethical Drugs, Biologicals, Vaccines, Biosimilars, OTCs.​

Differentiated ‘Science to Business’ approach​ Integrated services along the health value chain​, a roadmap can be articulated that enables product authorization, dossier compilation and post-authorization support.

Product Submissions

Our team will advise you to submit the regulatory application that best suits your needs, and also facilitate the authorization applications for products in the European territory acting as Marketing Authorization Holders.

  • Mutual recognition (MRP) and decentralized (DCP) procedures
  • National
  • MHRA exceptional procedures due to Brexit and will also advise you at all stages during the regulatory submission process
  • Initial application
  • Resolution of deficiencies
  • National phases

Our Services

  • Regulatory Strategy
    • Viability analysis
    • Compassionate use access requests
  • Analysis of the specific EU requirements
  • Submission of dossier and follow-up to approval
  • Contact with local Health Authorities
  • Support in meetings with Health Authorities
  • National phases in the different countries involved
  • xEVMPD (Art. 57(2))
  • MAH Service
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WHAT DO WE OFFER

Dossier Compilation

  • Review and consolidation of dossiers (eCTD)
  • Generation of the eCTD sequences and maintenance.
    • Necessary support to carry out the consolidation of dossiers, creating the necessary consolidation sequence for each client.
    • Development of eCTD sequences from a NeeS sequence or from separate documents for clients who do not have these software packages (simplification of the process and cost savings).
  • Expert reports (module 2)
  • Readability testing
  • Audits in RA departments

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Post-Authorization Support
Variations
Pricing &
Reimbursement
Translations & updates
of Product Information
Artworks review
& approval
ADPROM review
Communication of quality defects or shortages
Local regulatory activities
Annual marketing plans, maintenance fee, communication for putting on the market…
Writing & reviewing
expert reports

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+34 91 277 10 76

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8:30 AM – 6:30 PM

 

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