Advances Therapies & Co.

Hier können Sie nach Dienstleistern und Consultants rund um ATMPs, Biosimilars, Biological Products, Advanced Therapies (Gene/Cell) uvm. suchen. Die Liste erhebt keinen Anspruch auf Vollständigkeit und es kann keine Gewähr für die Richtigkeit und Aktualität der zur Verfügung gestellten Informationen übernommen werden.

Sollten Sie selbst Anbieter von Dienstleistungen in diesem Bereich sein, haben Sie die Möglichkeit, sich kostenfrei in dieses Verzeichnis einzutragen.


Heinrich Regulatory Affairs Consulting and Interim Management

Dr. Heike Heinrich

Fröhlichstr. 8

81479 München

T: +49 (0) 89 749 748 65

M: +49 (0) 162 4124168

Dr.H.Heinrich@t-online.de

Homepage

Regulatory expertise in a broad spectrum of active substances:

  • Advanced therapy medicinal products (ATMP)
  • Blood-derived products
  • Biologicals, Biotech
  • Biosimilars
  • New Chemical Entities (NCE)


Xendo Deutschland GmbH

Siemensdamm 62

13627 Berlin

Telefon: 030/856 06878-0

office@xendo.com

Homepage 

Xendo is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare.

Contact us in any phase of your product's lifecycle if you are looking for a partner in Product Development, Regulatory Affairs, (Pharmaco)vigilance or QA/QC.

 

  • RA management from early preclinical stage to the final steps of maintenance of the license
  • Dossier compliation and submission
  • CMC Program & Project Management
  • Investigational Medicinal Product Management
  • Formulation Development
  • Analytical Development
  • Product release (QP)


ERA Consulting GmbH 

Lange Strasse 70 

29664 Walsrode

Germany 

Tel: # 49 (0) 5161 9890 0 

Fax: # 49 (0) 5161 9890 18 

info@eraconsulting.com   

Homepage 

ERA Consulting is a strategic regulatory consultancy for products such as vaccines, personalised medicine products, novel mAb's, biosimilars, complex proteins, cell and gene therapies, gene editing, regenerative medicine and NCE’s. ERA’s expert consultants are providing support ranging from strategic input, agency interactions, through to the management and writing of dossiers for marketing authorisation and electronic submission and interactions with various regulatory agencies such as EMA (including all National Agencies), FDA, PMDA, TGA, Health Canada and Swiss Medic. 

 

  • Industry leading experience for regulatory and CMC advice on Cell and Gene Therapy Products including: allogeneic and autologous Cell Therapy products, Lentiviral/retroviral vectors, Adeno vectors, AAV vectors, other viral vectors, genome editing technologies, GMO assessment
  • PRIME, RMAT designation application
  • ATMP classification procedures
  • CMC authoring 
  • Compilation and submission of CTA, IND, pre-pre-IND, pre-IND packages
  • MAA, BLA and IND authoring, compilation and submission
  • Support for scientific advice and other agency interactions
  • Applications for Orphan Drug Designation (EMA, FDA)
  • Communication with regulatory agencies