Dr. Alexander Bachmann

MIA Service Provider for import and QP batch release of IMPs and authorized medicinal products

Strategic and operational consulting across the product lifecycle: • Development, registration and manufacturing of APIs and medicinal products • Quality Management, QA, QC and GMP Compliance • CMC and Regulatory Affairs: expert reports for Modules 1.4.1, 1.4.2 and 1.4.3 • QP services for IMPs, authorized medicinal products and APIs • Technology, process and analytical transfers • Business development, contracting, licensing and due diligence • Cross-functional project and interim management

Quality manager and transfer lead of mature medicinal products

Within the frame of global product portfolio transfer following cross-functional consultancy tasks: * Analytical & process transfers * Regulatory Affairs: - Module 3 - Module 5 - bioequivalence - Support tox assessments * Quality: QA, QC, compliance, cGMP * General consultancy/ expert opinion to meet internal SOPs/ quality standards, USP, EP, ICH, NTA and EU-cGMP

Design, implementation and maintenance of a quality management system from scratch to get/maintain a manufacturing authorization and to act as a QP for transdermal patches.

QP for IMPs

Consultancy concerning: * Module 3/ EU-cGMP - Excipients & packaging materials * Analytical & Tech transfer activities * General consultancy to meet Module 3, USP, EP, ICH, EU-cGMP and internal SOP standards

1. Represents Quality in transfer projects; generates the transfer planning and maintains its status oversight. 2. Responsible for the tight interactions / coordination between the local operative quality sites 3. Writing of the transfer documentation 4. Ensures that all activities in the area of responsibility comply with corporate/local SOPs, cGMP and other external regulatory requirements.

Local Project Management: technical project management and single point of contact by acting as an interface between local – global project teams. Regulatory Facilitation: to manage and facilitate on-site regulatory CMC related launch and post-approval activities (changes, transfers, remediation, divestment, pruning and due diligence) of the site specific products. Identification of compliance gaps between GMP and regulatory documentation. GMP compliance for FDA Readiness

Local cross-functional GMP project management: Update local GMP documentation to comply with latest Pharmacopoeias. Identification of compliance gaps between GMP and regulatory documentation. Write justification for health authorities in case skip testing is or can be applied/ incl. FDA Readiness.

Regulatory Affairs with focus on CMC: Ad interim leading, development and training of regulatory affairs teams

In- and out-licensing of pharmaceutical products from Europe to China/ USA and from China/ USA to Europe

GMP compliance for FDA Readiness

PhD thesis: ‘Pharmacological characterisation of components of the epithelial ATP-sensitive potassium ion channel in the kidney’. Tools: molecular biology (site directed mutagenesis, cDNA and mRNA synthesis in E. coli), electrophy

Diploma thesis at the Medical University of Hannover, Germany (Prof. Dr. Dr. B. Tuemmler) entitled “Kinetic of ß-lactame antibiotics and mutation analysis of the regulator gene ampR of multidrug resistant Pseudomonas aeruginosa isolates”