The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients. Freyr provided dedicated resources needed to meet our immediate regulatory filing requirements. All changes were handled within 24 hours and notifications of changes were promptly provided.
Health Authority Query Management Manage and track all the Health Authority queries at one place, thereby enabling speedy approvals.
Client Testimonials. Quick Inquiry. Simcyp: 20 Years of Innovation. Contact Investors Careers Support. Contact Us. Simplify complex regulatory processes Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document eCTD submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Learn more. Learn More. It allows the user to view submissions in a cumulative table of content, Regulatory, and study views.
Hence, users can minimize their errors before submitting to the Agency. Inbuilt eCTD viewer also allows to review legacy submissions of the product within the system without installing additional software. It enables users to create bookmarks, internal and external hyperlinks within the eCTD software.
The PDF manager also helps in securing the submission document with specified access controls for editing and viewing, making the eCTD submissions more manageable and safer. For example, if there exists a version of your submission in any external platform or tool, our eCTD solution allows you to migrate the same submission documents into the current system without hindering any procedure, which indeed enables better life cycle management.
While you plan to market the same product in different regions, it is well known that except eCTD Module 1, i.
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