Regulatory Operations Consulting
Nearly every regional authority has introduced updates to its eCTD validation criteria. Life science companies must quickly respond to these changes in global regulatory requirements, or risk errors. Factor in the lingering uncertainty following a flurry of consolidation in the vendor community, and the impending eCTD mandate from the FDA, and you can imagine why it’s critically important to have a partner with industry insight you can trust.
Our team of experts will work to streamline your existing submission process, and share eCTD best practices. First, we will work with you to identify any potential roadblocks that may impact the timing and/or quality of your eCTD submission. Based on our analysis and your feedback, we will propose resolutions and mitigations to those risks. We are also able to help generate submission-ready deliverables by engaging stakeholders upstream in the process. Our engaged support department and secure CLOUD-based software suite make remote collaboration easier than ever.
- Regional offices ensure effective communication and personalized attention
- Best practices to increase efficiency and prevent wasted effort
- Develop submission-ready deliverables to maximize benefits of the eCTD lifecycle
- In-house training for submission teams
- Advise on regional best practices
- Expert advice on changing regulation standards
GlobalSubmit’s relationship with the FDA and our track record of delivering high-quality submissions on time, with virtually no risk of rejection, are steadying assurances in volatile times.