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Dr. Matthias Brunner, Drug Regulatory Affairs & QA Consultant

Consultancy Portfolio – Core Areas of Service

• CMC regulatory strategies and support regarding pharmaceutical quality aspects of medicinal/drug 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'

• Writing and updating of Active Substance Master File (ASMF) / Drug Master File (DMF)

• Assessment, review and gap analyses of Module 3/2.3 documents

• Regulatory CMC/Change Management for active/drug substances and medicinal/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

• Support in Quality Assurance (QA)

• 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