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Product Development
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Clinical Trials
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Quality
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GxP Audits
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Regulatory Affairs
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Pre-authorisation
- Regulatory Roadmap
- Scientific Advice
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Product information
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Dossier preparation
- Dossier Gap Analysis
- MA Handling
- Post-authorisation
- Regulatory outsourcing
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Pre-authorisation
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Pharmacovigilance
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QP Service / Importer
Handling of the registration process
We have taken part in hundreds of marketing authorisation processes covering all types of procedures: purely national, European including decentralised, mutual recognition and repeat use procedures (DCP/MRP/RUP) and centralised (CP).
We had the pleasure of cooperating with different EU Competent Authorities (CA) such as AGES (AT), BfArM (DE), FAMHP (BE), BDA (BG), AIFA (IT), MoH (CY), SUKL (CZ, SK), OGYEI (HU), MMA (MT), INFARMED (PT), AEMPS (ES), URPL (PL) & others. In regards to non-EU CA, we have cooperated with CA such as MHRA (UK), Health Canada (Canada) or Swissmedic (CH).
Thanks to our wide experience we can support you in handling marketing authorisation procedures, including support in:
- eCTD compilation and dossier submission to CA,
- Active monitoring of national and European registration procedures,
- Full support during communication with national competent authorities and with EMA,
- Preparation of responses to deficiency letters,
- Coordination of registration procedures as “Central Coordinator” or as “Local Point” in mutual, recognition and decentralised procedures,
- Preparation of Product Information, including PI translation.