Regulatory Management

• 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

• 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.)

• 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

• 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

• 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

• 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 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

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 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

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.

• EU-MAA Management (CP, DCP, MRP, NP)
• Compilation and submission of MA dossiers
• Life-Cycle Management (variations, renewals, etc.)
• Regulatory Compliance and SWOT-Analysis
• Scientific Advice Support
• Regulatory Due Diligence
• Labeling & PI-Text Management
• Scientific Service & Informationsbeauftragter acc. to §74a AMG