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  • Zulassungsberatung für
    bio-/pharmazeutische Firmen

  • Zulassung von Arzneimitteln

  • Interim Management
    Arzneimittelzulassung

  • GxP Auditierung

  • Erstellung von Dossiers

  • Scientific Advice

  • Due Diligence

Expertise

Das Team besitzt weitreichende Kompetenzen auf den Gebieten der Arzneimittelentwicklung, der Herstellung und Prüfung, allen Facetten der Arzneimittelzulassung und GxP Fragestellungen und GMP Audits speziell für biopharmazeutische Arzneimittel und vermehrt auch für chemisch hergestellte Arzneimittel. Eine Aufzählung von Produkten und Beispiele erfolgreich abgeschlossener Projekte bieten einen Einblick in unsere Aktivitäten.

  • Impfstoffe aller Art
  • GMOs
  • Plasma- und Blutprodukte
  • Rekombinante Proteine
  • Rekombinante Antikörper
  • Zelltherapien
  • Neuartige Therapien
  • Medizinprodukte in Kombination mit biologischen Produkten
  • Pflanzliche Arzneimittel
  • Zytotoxische Arzneimittel
  • Interim Management Leitung Regulatory Affairs
  • Interim Management Leitung Compliance
  • Strategic Management: Strategic development of licensing routes
  • Mergers and Acquisition: Technical and Management Audits
  • Due Diligences: Product and project assessments
  • Project management
  • Scientific advice for various authorities in Europe and at the US FDA
  • Clinical Trial Applications: Project management for compilation and submission of dossiers like the Investigational Medicinal Product Dossier (IMPD) for the EU and the Investigational Brochure for the USA
  • INDs: Project Management and compilation of documents for several biopharmaceutical products
  • Orphan Designation Application: submission and maintenance process
  • Applications for market approval following the Centralised and Decentralised Procedure in Europe
  • Variations of Market Authorisation: compilation and submission
  • Renewal: compilation and submission
  • GMP audits at various contract manufacturers
  • GCP audits at various sponsors
  • Medical Device development

Klienten

Unsere Klienten sind bekannte kleine, mittelständische und große Pharmaunternehmen. Die Auflistung gibt eine Auswahl von erfolgreich abgeschlossenen Projekten der BioReg Consultancy wieder:

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:

  • Development of medical device with biological component
  • Compilation of a Biologics Master File for a recombinant protein for FDA submission

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:

  • Development of an antibody construct up to clinical trial phase II
  • GxP audits
  • Development of a cancer drug into clinical Phase II

Countries:
USA, Germany, France

Projects:

  • Due Diligence and GMP Audits of contract manufacturers
  • Renewal and license transfer for a biotech product
  • Interim Management Head Regulatory Affairs

Country:
USA

Project:
GMP audits.