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The team possess vast expertise in the fields of development, manufacture, regulatory affairs, regulatory compliance and GXP inspections for biopharmaceuticals medicinal products. Products covered and examples of successfully finished projects provide an insight into our activities.
Our clients are renowned micro, small and medium-sized biotech companies as well as large pharmaceutical companies. The following chart provides a selection of successfully accomplished projects by BioReg Consultancy:
Country:
USA and Germany
Project:
Interim Management of the Regulatory Affairs Department to set up of the affiliate in Germany as European Headquarters.
Country:
USA and Switzerland
Project:
Interim Management and Set-up of Quality Assurance and Regulatory Affairs for founding an affiliate and manufacturing site.
Countries:
Germany, United Kingdom
Projects:
Country:
Germany, Switzerland
Project:
Compilation of several dossiers for vaccines.
Country:
Germany
Project:
Development of a GMO vaccine up to clinical trial phase I and II.
Country:
Germany
Projects:
Countries:
USA, Germany, France
Projects:
Country:
USA
Project:
GMP audits.