Here you can search for regulatory affairs service providers covering diverse services around eCTD und eSubmission.
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.
Saidia Pharma Service Limited
Bei den Mühren 66a
Dr. Michael Klein
Michor Consulting and Trade Services GmbH
Eisinger Submission Management
ProPharma Group GmbH
Telefon: 030/856 06878-0
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.
ERA Consulting GmbH
Lange Strasse 70
Tel: # 49 (0) 5161 9890 0
Fax: # 49 (0) 5161 9890 18
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.
DocShifter is a software solution that takes all your digital content (Office documents, images, PDF, etc.) and transforms it into technically compliant PDF (for FDA, EMA, PDMA, etc.). Do you need format transformations in the context of submissions, data or document migration, digital archiving, correspondence management or data extraction for IDMP?
We connect to all your enterprise systems for document management, regulatory information management, quality management and many more. Centralizing this process ensures harmonization, reduces risk and cost.
File transformations include but are not limited to: PDF, PDF/A, Word, TIFF, JPEG. DocShifter transforms thousands of documents 10x faster and at higher quality than comparable solutions. Speeding up your submission process.
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.