Expertise

• Sourcing, development, registration and manufacturing of APIs and medicinal products

• Technology, process & analytical transfer

• Production, QA, QC

• Qualified Person

• Compliance/ cGMP

• Regulatory Affairs

• In- and out-licensing

• Business development

• Project/ interim management

• Due diligences/ aquisitions

Selected Projects

• German Pharma Company: Implementation and maintenance of a pharmaceutical quality

   system to get/maintain a manufacturing authorization and to act as a QP for transdermal patches

• Large global German Pharma Company: Quality and regulatory cross-functional consultancy

  within the frame of a global product portfolio transfer:
    - 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

• Large clinical supply service provider: Qualified Person for IMPs

• Large global German Pharma Company: 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

• Large global German Pharma Company: Analytical transfer projects

• Top Three Global Pharma Company: Technical & Registration Support

• Top Five Global Pharma Company: Local cross-functional GMP project management/ FDA

   Readiness

• Top Five Global Pharma Company: GMP compliance for FDA Readiness

• Global Pharma Company:  Evaluation of product portfolio for the German tender business

• Global Pharma Company: Regulatory affairs with focus on CMC:

  Ad interim leading, development and training on regulatory affairs teams

• Global Pharma Company: In- and out- licensing of pharmaceutical products from Europe to

  China/USA and from China/USA to Europe

• Lead global in-/out-licensing, linked to supply tie-ups of APIs and Medicinal products

• Top Five Global Pharma Company: Drive Respiratory Launch Readiness process

• Built up and developed RA and QA/QC department at the European headquarters of an Indian

  multinational generics player

• Several successful global generic developments (incl. Day One launches) and their supplies

• Several successful generic product transfers (incl. QA/CC) from Europe to Asia and vice versa

• Built up and development the manufacturing sites in Asia for the product launch of a global

   pharmaceutical company; implemented QA/QC system