Regulatory Compliance

Find providers of services in the field of regualtory compliance.

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.

Saidia Pharma Service Limited

Bei den Mühren 66a

20457 Hamburg

Germany

info@saidiapharma.de

Homepage 

  •     Regulatory Compliance Checks
  •     Gap Analyses


Diapharm GmbH & Co. KG

Hafenweg 18-20

48155 Münster

Germany

info@diapharm.de

Homepage 

  • Compliance audit of marketing authorisation and manufacturing documents
  • Gap analysis
  • Dossier updates/variation
  • GMP audits


3R Pharma Consulting GmbH

Wildbader Str. 3

75335 Dobel

Germany

tobias.zahn@3rpc.com

Homepage 

  • Gap analyses of regulatory documents and dossiers
  • Supplier qualification
  • GMP audits


ProPharma Group GmbH

Siemensdamm 62

13627 Berlin

Telefon: 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 Maintenance & Compliance
  • CMC Program & Project Management


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.

 

  • Gap Analyses of dossiers and regulatory documentation
  • Update of dossiers (e.g. post-approval variations, amendments etc.)
  • Assessment on change controls and support for associated regulatory activities


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.

  • Preparation audit inspection (incl. CAPA-management) compliance check
  • Implementing risk management approaches / FMEA analyses designing, implementing and optimizing your GxP-quality system
  • Quality management
  • Auditing
  • Gap analysis


Dr. Matthias Brunner,  Drug Regulatory Affairs Consultant

Hans-Bunte-Str. 8

69123 Heidelberg

Germany

Info@DRA-Consultant.eu

Homepage

  • Assessment of regulatory compliance (between regulatory dossier and manufacturing/control documentation, e.g. Master Batch Records, test instructions)
  • Regulatory CMC Management and Regulatory Change Management for active substances / drug substances and medicinal products / drug products
  • Subsequent writing and updating of chemical-pharmaceutical documentation (Module 3/2.3) and further regulatory CMC documents for active substances / drug substances and medicinal products / drug products for variations/changes
  • Responding to deficiency letters of competent authorities
  • Special expertise in quality aspects of nasal, ophthalmic and auricular products; tablets, capsules and sterile parenterals