Dossier / CMC writing

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

• 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

• 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

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

• 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

• 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)

• CMC Writing
• Quality Expert Reports
• Regulatory CMC strategy

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

• 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 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

• 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

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.

• 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