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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
Dossier preparation
Successful registration that results in the granting of a Marketing Authorisation (MA) is primarily dependent on the quality of the product dossier that is assessed by the Competent Authority. SciencePharma offers full support in completing the documentation in the appropriate format such as electronic Common Technical Document (eCTD) format.
Our service of dossier preparation includes all five modules:
- Module 1 – Regional Administrative Information containing among the others Module 1.2 Application Form,
Module 1.3 Product Information, Module 1.5 Specific Requirements for Different Types of Applications ,
Module 1.6 Environmental Risk Assessment (ERA), Module 1.7 Information relating to Orphan Market Exclusivity
and Module 1.8 Information relating to Pharmacovigilance - Module 2 – Overviews containing summaries on quality (QOS), non-clinical and clinical part of dossier
- Module 3 – Quality
- Module 4 – Non-clinical study reports
- Module 5 – Clinical study reports.
Our experts have extensive experience in the field of verification and preparation of documentation for medicinal products.
In the process of dossier preparation, we are in constant contact with both the marketing authorization holder and manufacturers, realizing how important this communication is to ensure that the information presented in the dossier is correct and sufficient for the evaluating bodies.
At the beginning of our cooperation, we become your active partner and will always try to find the best solutions!
Veterinary medicinal products (VMPs) are a separate issue and the mandatory dossier format in case of VMPs is VNeeS (Veterinary eCTD electronic Submission) format. VNeeS format is mandatory for submissions to EMA as well as for submissions in the Decentralised, Mutual Recognition and National Procedures.
The difference between eCTD and NeeS is that NeeS is essentially a collection of files organized in a series of folders. eCTD, on the other hand, is a more powerful option, facilitating easy dossier and lifecycle maintenance and navigation via an xml backbone.
