eCTDconsultancy: the Science of Submissions
eCTDconsultancy advises pharmaceutical and biotech companies on reducing time-to-submission by implementing strategies, processes and procedures related to scientific/strategic and operational aspects of drug development. We apply a scientific approach to working with Regulatory Submissions that ensures the highest possible quality of Regulatory Dossiers, with an ultimate aim of providing benefits to applicant, agency and patient.
We can assist pharma and biotech companies with the evaluation of available information and subsequent design for a well-balanced drug development program, and can coordinate regulatory procedures within the EU, US and Canada.
We are able to help pharma companies prepare for e-submissions (including non-eCTDs and eCTDs) by advising on:
- the adoption of processes for first-time-right authoring and publishing
- implementation of a standardized document or content management system
- implications of and best practice for document/dossier lifecycle management
eCTDconsultancy is software independent. We work to understand the specific requirements of your business and utilise an in-depth understanding of external specifications (and their impact on the management of scientific content) to further define these requirements. We can then partner with any software vendor to recommend and develop integrated solutions, incorporating:
- software implementation & configuration
- end-user training
- advice for adapting software to support changing business processes.
National Competent Authorities
National Competent Authorities (NCAs) can also benefit from our expertise. eCTDconsultancy can assist in preparation for eSubmissions (including NEESs and eCTDs) by:
- adapting review processes
- implementing a standardized document or content management system
- implementing a dossier lifecycle management/eCTD review tool.