Regulatory Management

Here you can search for regulatory affairs service providers covering a wide range of diverse services of product´s lifecycle.

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

20457 Hamburg

Germany

info@saidiapharma.de

Homepage 

  • Variations (national, MRP, DCP und CP)
  • Response to validation questions
  • Deficiency letters
  • Renewals
  • Roll-outs
  • eCTD Management
  • Expert Reports
  • Sunset Clause
  • Text Management
  • On site support


Phortas GmbH

Mariahilfstr. 16

52062 Aachen

Germany

info@phortas.com

Homepage

  • MAA/NDA management and preparation
  • Life-cycle maintenance (variations, renewals, line-extensions, etc.)
  • Submission strategy, planning and tracking
  • Dossier assembly and publishing
  • Labeling
  • Company Core Data Sheet CCDS
  • Communication with authorities
  • Scientific Advice preparations (US, EU, PMDA, etc.)


mikle-pharm GmbH 

Dr. Michael Klein 

Sandgasse 17

76829 Landau 

Germany

michael@mikle-pharm.com

Homepage

  • Compilation of application dossiers, submission, procedure management
  • Scientific Advice SA, Clinical Trial Application CTA, Marketing Authorisation Application MAA (NP, DCP, MRP)
  • Agency communication, follow-up
  • Variations, life cycle, regulatory compliance
  • Compilation of Baseline Dossiers
  • Dossier amendment: Variation Package
  • Dossier compilation: Briefing Document (for Scientific Advice)
  • IMPD (for Clinical Trial Application), CTD/ e-CTD (for Marketing Authorisation Application) co-ordination of activities (internal and external resources) including manufacturing sites, laboratory work, CRO and experts involved


Michor Consulting and Trade Services GmbH

Schönbrunnerstrasse 238/2/6

1120 Wien

Austria

office@michor-consulting.eu

Homepage

  • MA procedures: National Authorisations, Line Extensions, Mutual Recognition Procedures (MRP), Decentralised Procedures, Centralised Procedures
  • Post-approval/life cycle management
  • Compile CMC sections of your dossier to meet your deadlines in CTD format
  • Process format changes NTA to CTD for old product lines
  • Create module 3 in eCTD (for this companies must have appropriate document management systems in place)
  • Prepare application packages ready for submission to EU authorities, EMEA (European Medicines Agency) or the National Competent Authorities (CA)
  • Author quality overall summaries


Diapharm GmbH & Co. KG

Hafenweg 18-20

48155 Münster

Germany

info@diapharm.de

Homepage

 

  • Authorisation strategy consulting for human and veterinary medicinal products
  • Complete marketing authorisation management:
    o Centralised procedure (CP) at the EMA
    o Decentralised procedure (DCP) in all EU member states
    o Mutual recognition procedure (MRP) in all EU member state
    o National marketing authorisation with the proper regulatory agencies for medicinal products (ANSM, BfArM, DKMA, MHRA, MEB, etc.)
  • Full marketing authorisation, well-established use (WEU), fixed combination, informed consent procedure under 2001/83/EC, Article 8 (3); 10a–10c (DE: Section 22 AMG; Section 24a AMG)
  • Traditional registration (THMP) under 2001/83/EC, Article 16a–16i (DE: Section 39a–d AMG)
  • Generic, hybrid and biosimilar marketing authorisations under 2001/83/EC, Article 10 (1), (3) or (4) (DE: Section 24b AMG)
  • Marketing authorisation and registration of homeopathic medicinal products
  • Updating of existing dossiers to keep them in line with new legal requirements
  • Variations and renewals
  • Demands for changes and additional information (“deficiency letter”)
  • On- and off-site support


ELC-Group s.r.o

Karolinská 650/1,

186 00 Prague 

Czech Republic 

info@elc-group.com

Homepage

 

  • Data Gap analysis and revision
  • Dossier compilation as per country-specific guidelines
  • Global CTD/NeeS/eCTD conversion
  • Full-Life-Cycle Management – Renewals and Variations
  • Review of technical documentation
  • Agency deficiency management 
  • Submission management and liaising with agencies
  • Due diligence of dossier


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
  • RA management from early preclinical stage to the final steps of maintenance of the license
  • Dossier compliation and submission


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.

 

  • Authoring of responses to agency questions
  • Maintenance of MAA: Preparation and submission of post-approval variations, amendments, supplements etc., support for renewals
  • Submission strategy for post-approval variations, amendments, supplements etc.
  • Support for scientific advice and other agency interactions
  • Communication with regulatory agencies
  • Support for technical validation questions


Logo Pharmexon

Pharmexon Consulting s.r.o,

Krakovska 22 Prague 1

11000 Prague

Czechia

info@pharmexon.com

Homepage  

Whether or not we assisted in the development and submission, we are able to provide standalone or ongoing services for post-approval maintenance. This can range from long-term support of all variations, renewals, PV and eCTD versioning through to a standalone submission of a change request to an Agency. We understand that this activity is a cost-burden to industry, yet is necessary as part of ongoing compliance. We are able to provide services in Life-cycle management that could minimise costs and meet critical timelines in order to ensure MAs are kept up-to-date. 

Some of the services offered in this area are:

  • Variations, renewals, PSUR and eCTD lifecycle maintenance
  • Large volume variations, grouping for EU and minimise administrative burden for global submissions
  • Fully compliant dossier submission in most regulated regions
  • Support(technical, administrative and regulatory) for Deficiency response and coordination
  • Support of finalisation of procedure/national phase
  • Consolidation of renewals, preparation of dossier and submission
  • MA transfers and associated variations during acquisition transactions
  • Local representatives- mandatory for new submissions, variations (BG, SK, HU, HR)
  • Sunset Clause


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.

  • Initial marketing authorization applications
  • Full portfolio maintenance service across all regions
  • Global roll-out strategy for new submissions including due diligence activities
  • Consultancy and regulatory operations during M&A activities
  • Change control procedures, CMC writing for chemicals and biologicals