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Drug Regulatory Affairs

As service provider in the area of marketing authorisation of medicinal products pharmadocs stands for reliable service and high quality results. Specialised in the registration of medicinal products for human use we do not only provide regulatory consulting services prior to the registration. In addition we prepare, check and submit the relevant regulatory documents to the competent authority. From initial product reports and eCTD-Services through product information texts and variations – we offer our partners a full service in the area of drug regulatory affairs. In doing so, we collaborate with the competent authorities in both national and international context in a structured way and have the different deadlines of our partners always under control.

Our services:

  • Strategy development and planning of approval procedures
  • Authority correspondence and advice on authority matters
  • Submission, implementation and supervision of national procedures (EU and non-EU) and mutual recognition procedures (MRP), decentralised procedures (DCP) and centralised procedures (CP)
  • New registration dossiers for human drugs, modules 1-5 CTD (NtA Vol. 2B)
  • Evaluation and updating of existing registration dossiers and creation of the necessary modules
  • creation, review and updating of product information texts coordination of translations
  • eCTD creation
  • Electronic submission of applications for approval (eSubmission)
  • EudraVigilance (xEVMPD): Product Initial Report
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eCTD Service

While the eCTD obligation for European procedures is already binding or will soon become binding, the European Medicines Agency (EMA) has extended the deadline for national approvals to 01.01.2019. The administrative effort was greater than expected. From 01.01.2019, the eCTD obligation will then apply to all approvals and amendments and will become the standard throughout Europe. We meet all technical requirements and have the necessary knowledge for a smooth submission of the registration documents in eCTD format.

Our services:

  • Preparation, validation and submission of the registration dossier in eCTD format
  • Reformatting to eCTD
  • Creation of an eCTD baseline
  • Maintenance of the eCTD dossier in Life Cycle Management
  • Digitisation of paper documents
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Regulatory advice

The potential of a drug depends on different market factors and a variety of regulations.
We know the legal requirements and know what possibilities and special features exist nationally and internationally. Accordingly, we specifically address your regulatory issues, provide comprehensive advice and develop the appropriate concept.

Our services:

  • Evaluation of internal and external processes
  • Strategy development for process optimization
  • SOP creation and implementationProduct evaluation, classification and classification of the product category
  • Analysis of existing data and preparation and request for the necessary documents
  • Strategy development for approval
  • cost-benefit analysis
  • due diligence
  • Consultations with drug authorities
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Regulatory Writing und Artwork

Already from the development and testing phase and throughout the entire product cycle, numerous results are produced, which must be processed in a structured and comprehensible form. We use this data to produce high-quality, legally compliant medical texts in accordance with the latest regulations.

Our services:

  • Creation and revision of labelling, instructions for use and
  • Specialist information in English and German
  • Review and release of the artwork
  • Revision and review of advertising materials
  • Creation, review and updating of product information texts
  • Creation of Company Core Data Sheets (CCDS)
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Regulatory requirements can change at any time, which in turn requires urgent adjustment measures for drugs already on the market. We evaluate these with care and know how to intervene in good time.

Our services:

  • Evaluation of existing dossiers
  • Updating existing dossiers
  • CMC compliance check
  • Preparation of administrative and country-specific documents (module 1)
  • Creation, review and updating of product information texts
  • Coordination of translations
  • official correspondence
  • Planning, implementation and submission of variations
  • Planning, implementation and submission of renewals
  • Coordination and submission of Periodic Safety Update Reports (PSUR)
  • Scheduling and deadline planning of variations, renewals, notices of defects and conditions
  • EudraVigilance (xEVMPD): Deadline management and maintenance of existing database entries (EURD / DLP)