Find out more about our Global and specific services

REGULATORY

  • Global Regulatory Strategy.
  • Dossier Updating and Preparation.
  • Audit / Evaluation of the file.
  • Constitution of Module 1.
  • Drafting of administrative parts ( including SmPCs, package leaflets and labels ).
  • Carrying out the readability test of the package.
  • Translation of Texts.
  • Submission for new MA application within DCP, MRP and National Procedures.
  • Answering Technical Agency Questions during Registration.
  • Follow-up of the Procedure with the Authorities until the Authorization is obtained.
  • Publishing: using Extedo’s eCTD ManagerSoftware.
  • Preparation of Technical Documentations: Module 1, Module 2, Module 3, Module 4 and Module 5.

  • Maintenance of MA’s.
  • MA-Renewals.
  • Variations types IAIN, IA, IB, and II.
  • Transfers of MA’s.

  • Create e CTD publishing / formatting sequences.
  • Submit to European Authorities.
  • Submission via member country portals, CESP, eSubmission Gateway, CESSP, etc.

  • CE Marking, Registration / Certification, Preparation of Technical files, Mandatory Procedures, Total Quality Assurance.

  • QP declaration for regulatory purposes
  • Import of batches
  • Batch Testing and Certificate of Analysis
  • Documentary review
  • Batch Certificate for release

CLINICAL

  • Full Project Management.
  • Management of Budget and Project Timelines.
  • Clinical Tests Design.
  • Preparation and Submission of Clinical Documentation ( such as Protocol, IMPD, etc…) for the clinical trial request to the Competent Authorities and the Ethic Committee.
  • Post-submission activities support, including answering questions, amendments ( substantial, non-substantial ) and trial notifications.
  • Clinical Trial Monitoring:
  • Site Feasibility and Qualifications visits.
  • Initiation, Routine Monitoring and Closeout Visits.
  • Source Documentation Review and Data Verification.
  • Regulatory Compliance Support and Review.
  • Reporting of Adverse Events and Serious Adverse Events.
  • Identification and addressing of Protocol Deviations & Violations.

  • Trial Protocols and Amendments.
  • Model Informed Consent forms.
  • Clinical Study Reports ( CSRs).
  • Non Clinical Overviews and Summaries.
  • Scientific Advice at Agencies.

PHARMACOVIGILANCE

  • EU-QPPV / Local– QPPV.
  • 24-hour phone contact.
  • Signal monitoring and detection.
  • Handling, Management and Submission of ICSR.
  • Eudravigilance Registry and Maintenance.
  • Preparation and Maintenance of the Pharmacovigilance System Master File.
  • Monitor International Literature.
  • Preparation and Submission of Safety Variations.
  • Development, Revision and / or Update of Risk Management Plans ( RMP ).
  • Pharmacovigilance in Clinical Trials.

ECOTOXICITY

  • Log Kow and Koc Calculations.
  • PEC Surface water Calculation.
  • PEC/PNEC simulations.
  • Reports to Justify Phase II test during Regulatory process.
  • Lumbriculus sp OECD 225.
  • Chironomus sp OECD 218/235.
  • Hyalella sp.
  • Ready Biodegradability OECD 301.
  • Koc OECD 121.
  • Terrestrial ecotoxicity Tests: OECD 307, OECD 216, OECD 208, OECD 232.
  • Algae OECD 201.
  • Daphnia reproduction OECD 211.
  • Fish Early Life OECD 210.
  • Activated sludge, respiration inhibition OECD 209.

Our Expertise

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Product Registrations

DCP's in almost all countries in Europe. Working with orphan drugs and very niche products. Variations of all kinds, scientific advices at agencies, full management of clinical studies and complex technical answer reports.

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