Dossier / CMC writing

 

Here you can search for providers for the following services: compilation of MA dossiers, technical writing, CMC writing etc. The list is not intended to be exhaustive and no guarantee can be given for the correctness and timeliness of the information provided. Furthermore, please note that this list does not have any recommendatory character.


Phortas GmbH

Mariahilfstr. 16

52062 Aachen

Germany

info@phortas.com

Homepage

  • Dossier assembly and publishing
  • Clinical Trial CMC activities
  • NDA/MAA Module 3 preparations
  • Life-cycle CMC updates


mikle-pharm GmbH 

Dr. Michael Klein 

Sandgasse 17

76829 Landau 

Germany

michael@mikle-pharm.com

Homepage

  • writing of quality dossiers (Briefing Packages, IMPD, Module 3)
  • expert statements, summaries/ overviews (e.g. CTD Module 2) 
  • consolidation of dossiers: identification of valid dossier sections from archives containing many variations
  • compilation of Baseline Dossiers
  • compilation of Module 1


Michor Consulting and Trade Services GmbH

Schönbrunnerstrasse 238/2/6

1120 Wien

Austria

office@michor-consulting.eu

Homepage

  • 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 variation packages for your module 3
  • Author quality overall summaries


Eisinger Submission Management

Kirchweingarten 14

A-2102 Bisamberg

Austria

kurt@eisingersubmissions.com

Homepage 

  • CMC / Module 3 preparation
  • gap analysis
  • baseline dossier compilation


Diapharm GmbH & Co. KG

Hafenweg 18-20

48155 Münster

Germany

info@diapharm.de

Homepage 

  • Dossier preparation of human and veterinary medicinal products
  • Planning, preparing and updating
  • Evaluation of existing dossiers, gap analysis
  • Reformatting NtA > CTD and CTD > eCTD
  • Complete maintenance of existing documentation


3R Pharma Consulting GmbH

Wildbader Str. 3

75335 Dobel

Germany

tobias.zahn@3rpc.com

Homepage

 

  • Generation of reports, summaries, expert statements, briefing books; 
  • Generation and signing of Module 2 Quality Overall Summaries (QOS) for active substances and medicinal products for human use; 
  • Compilation of Common Technical Document (CTD) Module 3 required for 
    - Clinical Trial Applications (CTA, IND), IMPD
    - Applications for Marketing Authorisations (MAA in Europe) or New Drug Applications (NDA, BLA and ANDA in the US)
    - Drug Master Files (DMF) / Active Substance Master File (ASMF)
    - Certification of suitability of monographs of the European Pharmacopoeia (CEP)


ELC-Group s.r.o

Karolinská 650/1,

186 00 Prague 

Czech Republic 

info@elc-group.com

Homepage

  • CMC Writing
  • Quality Expert Reports
  • Regulatory CMC strategy


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-CMC
  • Environmental Risk Assessment
  • Regulatory Dossier Writing
  • Product Quality Review & Management Reviews
  • Design & execution of Validation Master Plans
  • Process & product validation
  • Analytical method validation
  • Cleaning validation


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.

  • CMC writing and advice on CMC relevant topics
  • Authoring of Module 2.3 and 3 
  • Authoring of Module 2.4 and 2.6 
  • Preparation and authoring of post-approval variations and amendments
  • Assessment on change controls and support for associated regulatory activities
  • Authoring of scientific advice briefing packages (EU and US)
  • Consolidation of dossier sections
  • Gap Analyses of existing dossiers and documentation
  • Compilation of Module 1 (EU, US, Australia)
  • Preparation of Quality Expert Statements
  • Regulatory CMC Strategy


Pharmexon Consulting s.r.o, 

Krakovska 22, Prague 1

11000 Prague

Czechia

info@pharmexon.com

Homepage 

  • Module 1-5 preparation, submission management, MA holding activities and coordination with HA
  • Authoring of Documentation for all Modules for CTD format 
  • Dossier Due Diligence
  • Gap analysis, review of Module 3
  • Expert medical writing- including sign off of the expert together with his CV


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.

  • Strategic consultancy during pharmaceutical development and lifecycle management Compilation of quality dossiers (ICH and non-ICH)
  • CMC and technical writing
  • GxP services (GMP, GACP, GDP) including audits


Dr. Matthias Brunner,  Drug Regulatory Affairs Consultant

Hans-Bunte-Str. 8

69123 Heidelberg

Germany

Info@DRA-Consultant.eu

Homepage

  • CMC regulatory strategies and support regarding pharmaceutical quality aspects of medicinal products for MAA/NDA, clinical trial applications (CTA/IMPD/IND) and developmental projects
  • Writing and updating of chemical-pharmaceutical documentation (Module 3/2.3) and further regulatory CMC documents for MAA/NDA, variations/changes, clinical trial applications (CTA/IMPD/IND) and developmental projects
  • Module 3/2.3 preparation in CTD/eCTD format, in required granularity for eCTD submission
  • Creation of EU ‘Baseline Dossier’
  • Assessment, review and gap analyses of Module 3/2.3 documents, creation of deficiency lists
  • Responding to deficiency letters of competent authorities
  •  Writing and updating of Active Substance Master File (ASMF) / Drug Master File (DMF)
  • Consolidation of dossiers (e.g. from fragments, past variations)
  • Transformation/re-formatting of legacy chemical-pharmaceutical documentation (e.g. paper/NtA/NeeS -> CTD; CTD -> eCTD)
  • Assessment of regulatory compliance
  • Special expertise in quality aspects of nasal, ophthalmic and auricular products; tablets, capsules and sterile parenterals


Contact: info@scendea.com

Homepage

 

Head Office address:

Scendea Ltd

20 The Causeway

Bishop’s Stortford, Hertfordshire,

CM23 2EJ

United Kingdom

Tel: +44 (0)1279 656 305

 

EU Office:

Scendea (NL) B.V.

De Cuserstraat 93

1081 CN Amsterdam

The Netherlands

Tel: +31 (0)208 949 169

 

US Office:

Scendea (USA) Inc.

Suite 110

5764 Pacific Center Blvd.

San Diego, CA 92121

USA

Tel: +1 619 793 4511

Fax: +1 858 295 1477

 

Scendea is a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. We are committed problem solvers, redefining the meaning of customer service, with a focus on reducing time-to-market and minimising development costs.  A combination of scientific excellence, industry experience and a collaborative approach enable us to deliver high-quality innovative solutions, which allow our clients to succeed.  Our international team offers strategic and operational support in the fields of quality/CMC, non-clinical/toxicology, clinical/medical and regulatory, which guide products efficiently from early development to marketing approval.

 



balticpharmasolutions GmbH

Papenreye 65

22453 Hamburg

Germany

info@balticpharmasolutions.de

Homepage 

  • Dossier compilation: pharmaceutical-technical documentation (eCTD- Module 3 & 2.3)
  • Expert reports
  • Support of technology transfer projects (API & FP) & compilation of technology transfer protocols 
  • Dossier compliance checks
  • Dossier updates for well-established products
  • Baseline dossiers