Registration

The correct Marketing Authorization application for a medicinal product, together with product particularities and complex regulatory requirements are key steps to be considered to ensure timely product commercialization in strategically defined markets.

Registration

Following evidence generation that indicates a product has the successful adequacy to treat a medical need, an appropriate regulatory registration procedure is required prior to commercialization.

This entails the definition, execution and formatting of registration eCTD dossiers and their management in terms of timing and content presentation, which are usually subject to standard formats and procedures requested by multiple authority bodies in each regulatory framework. This involves also a contextualization of such procedures regarding the type of product and the medical need to be covered.

Asphalion’s expertise aims at ensuring timely commercialization given the complexity of multiregional contexts, which requires a proper planning and management of document submission and product registration.

Following evidence generation that indicates a product has the successful adequacy to treat a medical need, an appropriate regulatory registration procedure is required prior to commercialization.

This entails the definition, execution and formatting of registration eCTD dossiers and their management in terms of timing and content presentation, which are usually subject to standard formats and procedures requested by multiple authority bodies in each regulatory framework. This involves also a contextualization of such procedures regarding the type of product and the medical need to be covered.

Asphalion’s expertise aims at ensuring timely commercialization given the complexity of multiregional contexts, which requires a proper planning and management of document submission and product registration.

Our Solutions

  • Support and Management of new marketing authorization submissions to comply with critical timelines
  • Assessment of regional requirements
  • Centralized Procedures (CP) in EMA
  • Decentralized Procedures (DCP) with all European Agencies and National Phases (NP)
  • FDA projects (IND, NDA, BLA, ANDA)
  • Local support in UK registrations using the new national portal.
  • Management of Spanish authorities’ portals and databases (e.g., RAEFAR)
  • Marketing Authorization transfers
  • Reliable coordination of local partners for global registration procedures (ROW)
  • Translations management for regulatory submissions processes. More specifically, in EU Centralized Procedures we manage translations from pre-opinion up to linguistic review and opinion by agencies
  • Module 1 for new MAA.
  • Elaboration of pre-clinical sections (Module 2.4 and 2.6)
  • Elaboration of clinical sections (Module 2.5 and 2.7)
  • Elaboration of CMC sections (Module 3)
  • Expert’s signature
  • Gap analysis and update of CMC: non-clinical and clinical sections
  • Technical documentation: scientific reports
  • Readability tests for all types of EU registration procedures
  • Transparency compliance (Policy 0070): documentation masking, anonymization reports
  • Adequate registration for regional authorities: AEMPS, EMA, UK and FDA
  • Due Diligence of in-licensing dossiers
  • Expert support on responses to Deficiency Letters
  • Comprehensive eCTD services
  • eCTD compilation and publishing
  • Full life cycle support for Europe, USA, Canada, Switzerland, Saudi Arabia, GCC, and more
  • Information management (RIMS solution)
  • Software installation, training, validation and support
  • Data consolidation for evidence presentation in submissions
  • Adequation and data retrieval and management to ISO IDMP standards
  • Tool review and selection (RFP, RFI)
  • Tool and process adaptation and implementation
  • Data mapping with SPOR master data
  • Gap analysis of IDMP readiness
  • Conformity assessment for medical devices: Medical device EU Certification Procedure assistance
  • Country-specific medical device regulatory support
  • Product registration
  • Assistance with local Competent Authorities communication and other local requirements
  • General safety and performance requirements
  • Risk analysis
  • Clinical Evaluation Reports (CERs)
  • Instructions for use and labelling

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Why Asphalion?

Asphalion has a focused expertise in complying with challenging regulatory requirements, highly tailored for a wide diversity of regional contexts in which multiple agents intervene and allows Asphalion to be a leading partner on the execution, presentation and follow-up of technical regulatory documents, which allows contextualized product registration and maximized efficiency.

At Asphalion we know the requirements that documents must meet in order to be timely approved, especially in dossiers for registration procedures, such as CTD, technical documents for scientific reports or transparency compliance reports.

We cover all aspects, starting from scientific and medical writing, up to support of the registration procedure in compliance with the regulations of each country.

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