Advanced Therapies & Co.

Find providers or consulting companies for various services and solutions in the field of advanced therapies (ATMP) such as gene therapy medicinal products, somatic cell therapy medicinal products or tissue engineered products. 

The list does not claim to be complete and no guarantee can be given for the correctness and up-to-dateness of the information provided. Furthermore, please note that this list does not have any recommendatory character.

If you are a provider of services in this area, you have the possibility to register free of charge in this directory.

ProPharma Group GmbH

Siemensdamm 62

13627 Berlin

Phone: 030/856 06878-0

regulatory.de@xendo.com

Homepage 

ProPharma Group GmbH 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


PharmaLex GmbH

Harrlachweg 6

68163 Mannheim

Germany 

Homepage

PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.

 

We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.

 

The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.

Full regulatory support for development, authorization and lifecycle management

  • Consulting on appropriate development strategies (e.g. biodistribution, tumorigenicity, orphan designation)
  • Support for specific procedures including classifications, certifications, Orphan designations, SME application, GMO application
  • Preparing and participating at ITF, SA at EMA or national authorities and FDA
  • Facilitating the communication with scientific committees of EMA (e.g. CAT, PDCO, COMP) and FDA (e.g. Advisory Board meetings)
  • Writing of documents for clinical trials in EU or US (i.e. IMPD, IND, IB)
  • Development of PRIME, hospital exemption, compassionate use for patients and early access programs
  • Developing and writing of paediatric investigation plans
  • Writing or review of all CTD documents for MA applications