Pre-submission
- Regulatory Strategy
- Audit dossier
- Management of laboratory authorization applications
- Prepare a new dossier to be submitted
- Dossier compilation
Regulatory Affairs
At Azierta, we are specialists in Regulatory Affairs with Global turnkey solutions, including Ethical Drugs, Biologicals, Vaccines, Biosimilars, OTCs and Animal Health.
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.
Procedures
- Support and management of new Marketing Authorization Application submission:
– National procedure (NAP)
– Decentralized procedures (DCP)
– Mutual Recognition procedures (MRP)
– Repeat Use Procedure (RUP)
- Support and management new ASMF/CEP submission
- International submission
- Veterinary Medicines
Submission
- eCTD compilation and publishing
- Submission of eCTD using Agencies’ gateways and portals
- Support and management deficiency letters
- AMP in XEVPMD
Commercialization
- Request National Codes
- Request Price & Reimbursement
- Management XEVPMD to PMS
Post-authorisation
- Full lifecycle support:
–Variations
– Renewals
– Withdrawals
– Withdrawals
- Reviewing Promotional material
- National phase: Labelling, summary of product characteristics, leaflet.
- Reviewing packaging material
- Management commercialized status
- Annual marketing intention
Veterinary Medicines Regulation Services
From Azierta our experts will be able to advise and accompany you in the process of Registration and Post-Marketing of Veterinary Medicines, always complying with the New Legislation in force (Regulation (EU) 2019/6).
- Registration of Veterinary Medicines
- National phases variations
- Review of artworks
- (AWs) and packaging material
- Temporary suspension, withdrawals, changes in the marketing status.
- Management of databases (RAEVET, CIMAVET, UPD)
- eCTD sequences
- Declaration of antibiotics (ESVAC Project)
- Regulatory consultation
Veterinary Medicines Regulation Services
From Azierta our experts will be able to advise and accompany you in the process of Registration and Post-Marketing of Veterinary Medicines, always complying with the New Legislation in force (Regulation (EU) 2019/6).
- Registration of Veterinary Medicines
- National phases variations
- Review of artworks (AWs) and packaging material
- Temporary suspension, withdrawals, changes in the marketing status.
- Management of databases (RAEVET, CIMAVET, UPD)
- eCTD sequences
- Declaration of antibiotics (ESVAC Project)
- Regulatory consultation
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
- Veterinary medicines regulation services
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
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
Do You Need Assistance? Contact Our Experts
Just send us your questions & we will give you the help you need.