An Extension of Your Regulatory Department
The skills needed to confidently compile an electronic regulatory submission take years of on-the-job training, industry immersion and regulatory study to develop. Full or partial outsourcing to a proven eCTD partner is often the most cost effective solution, and one that gives your organization the flexibility to allocate resources to other projects.
GlobalSubmit offers professional services to complete all aspects of an eCTD submission. The depth of our experience and knowledge acquired from our work with the US FDA, ICH, HL7 and industry groups is made available to our partners. Our team can guide your organization through compilation of an original submission, perform submission maintenance and step in to support your internal staff during workload peaks.
Outsourcing services are particularly helpful for small to mid-size businesses who are dealing with the following circumstances:
- Filing multiple submissions in a short-time period
- Small regulatory team with competing priorities
- Staff with an understanding of eCTD concepts, but little to no hands on experience
- Transitioning from paper to eCTD
- Concerns about expenditures to bring on and train new personnel
- Facing risk – and anticipating benefit
Our services team uses GlobalSubmit’s full eCTD software suite, which introduces efficiency, accuracy and automation into the publishing process. We are able to deliver high-quality submissions with minimal wasted effort. The time-saving nature of our products gives us the luxury of performing all submission activity domestically out of our corporate headquarters in Philadelphia, PA or our satellite office in San Diego, CA. We do not offshore any of our work, enhancing communication and improving the client experience.