Regulatory Services

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.

Regulatory Submission and Publishing Services

Synchrogenix offers regulatory submission and publishing services for marketing and pre-marketing applications, as well as subsequent lifecycle submissions (amendments, supplements, and reports) to support those original applications.

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 clients. Our Regulatory Services 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 submission and publishing 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
  • Converting from paper to eCTD
  • Concerns about expenditures to bring on and train new personnel
  • Facing risk – and anticipating benefit

Our Regulatory Services team uses GlobalSubmit’s Submissions Management 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 offices in Boston, MA or Research Triangle Park, NC. We do not offshore any of our work, enhancing communication and improving the client experience.

Download our guide, Implementing eCTD Through Outsourcingto learn more, or watch our video: