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Netzwerktag für Selbstständige mit Barcamp am 14. + 15. Oktober 2024
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Dr. Matthias Brunner

Drug Regulatory Affairs & QA Consultant

Pharmazeut. Industrie, Arzneimittelzulassung

Vereinsmitglied
Telefon
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Adresse
Hans-Bunte-Str. 8
69123 Heidelberg

Über mich

Your Partner in all Topics around the CMC Regulatory Dossier

Consultancy Portfolio:

  • CMC regulatory strategies and support regarding pharmaceutical quality aspects of medicinal products for MAA/NDA, clinical trial applications (CTA/IMPD/IND) and developmental projects
  • Writing and updating of chemical-pharmaceutical documentation (Module 3/2.3) and further regulatory CMC documents for all regulatory purposes
  • Module 3/2.3 preparation in CTD/eCTD format, in required granularity for eCTD submission Creation of EU 'Baseline Dossier'
  • Assessment, review and gap analyses of Module 3/2.3 documents, creation of deficiency lists
  • Regulatory CMC Management and Regulatory Change Management for active substances / drug substances and medicinal products / drug products
  • Assessment of regulatory compliance
  • Responding to deficiency letters of competent authorities
  • Consolidation of dossiers (e.g. from fragments, past variations) Transformation/re-formatting of legacy chemical-pharmaceutical documentation
  • Microbiological aspects and testing strategies for unpreserved dosage forms in multi-dose containers
  • Special expertise in quality aspects of nasal, ophthalmic and auricular products tablets, capsules and sterile parenterals
Dr. Matthias Brunner Schließen
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