eCTDconsultancy was founded in January 2006 by Hans van Bruggen. We are located in Waalwijk, The Netherlands.
Our consultants possess extensive previous experience of Drug Development and electronic Regulatory Submissions, including:
We can be seen presenting regularly at DIA Europe, Open-eCTD and Informa conferences and have good contacts with opinion leaders from both industry and agency. One of our key aims is to ensure that the ICH and regional specifications are meeting the requirements of agencies and of all sizes of companies (from large multi-nationals to small biotech companies to generics companies). We strive to use our understanding and experience of both scientific content and information management concepts to benefit these specifications and submit change requests whenever appropriate.
- Preparation of the first eCTD on a New Chemical Entity worldwide
- Preparation and submission of the first eCTD for a Centralised Procedure in the EU
- Design and implementation of Global Document Management Solutions
- Design and implementation of company eCTD strategies
- Establishment and management of a Regulatory Operations Department
- Coordination of the preparation of National, Decentralised and Centralised Procedures
- Authoring of Investigator's Brochures, Expert Reports, Quality Overall Summaries, Non-Clinical and Clinical
- Authoring and review of CMC, Non-Clinical and Clinical Reports
- Due diligence related to multiple license candidates
Our sister company, Qdossier, compliments the consultancy services we offer by providing a full range of document publishing, dossier preparation and hosting services.
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