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Dr. Matthias Brunner, Drug Regulatory Affairs Consultant

Consultancy Portfolio – Core Areas of Service

• Regulatory strategies and support regarding pharmaceutical quality aspects of medicinal products in MAA and developmental projects

• Writing and updating of Module 3/Module 2.3 (CMC) documents for MAA, variations and for clinical trial applications

• Module 3/2.3 preparation in CTD/eCTD format; creation of EU ‘Baseline Dossier’

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

• CMC Management and Change Management for active substances (drug substances) and medicinal products (drug products)

• Regulatory compliance

• Responding to deficiency letters of EU and international authorities

• Technical assessment for MA procedures and legal cases

• Microbiological aspects and testing strategies for unpreserved dosage forms in multi-dose containers

• Special expertise in quality aspects of nasal, ophthalmic and auricular products

• Review and update of labelling documents

• Internet and data base enquiries regarding pharmaceutical quality and toxicological topics

• Assessment on applicability of current laws and regulations

Printable Portfolio