Regulatory operations
To make sure that your application conforms with all other requirements beside the scientific requirements, we support regulatory operations and provide publishing services.
Regulatory operations:
- (Bio)Pharmaceuticals
- Prepare documents to be added in Module 1 of the CTD such as the cover letter, application form, tracking table/life cycle management table, review guide etc.
- Arrange legalization of hard copy signed documents by embassy and/or apostille
- Assess fees to be paid to health authorities and advise on the fee payment processes
- Submit dossiers to health authorities through the applicable web portals
- Maintain registration databases
- Medical Devices
- Project management including submission/certification planning
- Quality system operations
- Medical device technical documentation management, e.g. help to setup and maintain a database with version-managed documentation such that all product compliance information is available for submission/certification and recertification audits
- Submit conformity assessment request with EU Notified Bodies and agency notifications
- Unique Device Identification (UDI) data management
Publishing services:
- (Bio)Pharmaceuticals
- Prepare company CTD template documents (MS Word)
- Advise your team how to use the company template documents to author eCTD compliant documents
- Convert MS word documents to eCTD compliant PDF documents
- Publish dossiers in eCTD and NEES format
- Medical DevicesPrepare
- Technical Documentation templates (MS Word and Excel)
- Advise on the documentation templates to be used for the applicable reviewing agency and route of conformity for your product(s)
- Submission archiving