Dr. Matthias Brunner

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