Dr. Alexander Bachmann

Technical and BD Area with major focus on Europe and Asia: * sourcing, development, registration and manufacturing of APIs and medicinal products * analytical & process transfers * Qualified Person * quality/ GMP/ compliance * Regulatory Affairs: Module 1, 2, 3 and 5 * in- and out- licencing * due diligences/ acquisitions * project/ interim management

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

Evaluation of product portfolio for the German tender business

Drive Respiratory Launch Readiness process

Global R&D, manufacturing, registration, in- and out-licensing of generics and OTC products as well as organisation and handling of Day-One-Launches (incl. import of goods from third countries into the EU). Responsible for duly new product supply of the parent company. Built up and restructured the Woerwag R&D GmbH to a profit unit with running 18 R&D projects and a yearly budget of 2.5 – 4 Mio. €; clopidogrel generic medicinal product was developed within one year’s time and successfully launched.

Head European Regulatory Affairs and Portfolio Management, Qualified Person responsible for Pharmacovigilance (UK), Head Quality Control and Quality Assurance, participation in the development of added value projects and in in-/ out-licencing activities, training of Indian Torrent staff, organisation and handling of Day-One-Launches (incl. import of goods from third countries into the EU), Customer Relationship Management, handling of GxP issues, in-house consultant.

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”