Regulatory Filing Services

Regulatory Filing Services

The contents of a regulatory submission convey the first impression the FDA will have of your product and the quality and professionalism of your organization. It has been proven consistently that the success of a new product application is dependent on the effectiveness of the organization’s submission team and the working relationship developed between this group and the agency review team.

Recently a new application for a drug product was submitted and approved in approximately 9 months. The contents of the application presented more than 13 years of research and development activities conducted in more than one facility in The United States, Germany, and Switzerland. The planning and preparation of the NDA was a challenge for both the company and the FDA review team. Because of the long and complex development history there were huge amounts of data available that had to be evaluated in the application. Planning involved the review and organization in pre-filing meetings – both in person and by telephone conference – on the contents and presentation of the data spanned nearly 18 months.

One of the first challenges was organizing the data in a manner that could be included in a meeting package for the first of several pre-filing meeting. Several topics were discussed, specifically determining the readiness of the submission for filing. During a series of meeting, specific statistical analyses were discussed and agreed upon for inclusion in the final submission.

The submission team from the company and the FDA review team worked together to find the optimal solution to present the data in the most efficient manner, including abbreviated reporting strategies, electronic review aids, and the inclusion of comprehensive tabular and narrative summaries for each technical section. Each discipline (chemistry and manufacturing, pharmacology, and toxicology, clinical/medical biopharmaceutics, and statistics) was reviewed and discussed prior to the finalization of the sections of the NDA. To facilitate the review process, every effort was made to eliminate all redundancies and provide very detailed index features throughout the paper volumes of the NDA.

Electronic documents included bookmarking and hyperlinking to assist the reviewers in navigating through multivolume reports and sections. Case report forms and case report tabulations were provided electronically, not only facilitating the review but also saving on application preparation time. The electronic files were tested by the FDA reviewers prior to submission of the NDA to determine if the files were as specified during pre-filing discussions. The testing was invaluable for early identification of some minor formatting problems that were resolved prior to submission.

Synergy Bioscience can assist you in your submissions for any investigational new drug application (IND), Investigational Device Exemption (IDE), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologics License Application (BLA), device premarket notification (510 k), or device Premarket Approval Application (PMA).

While the documents were being reviewed and summaries were being prepared, the facilities were readied for inspection. Synergy Bioscience experts evaluated the facility and assisted in the final preparations to ensure readiness for the inspection.

An electronic file management system and publishing tool was utilized to organize, paginate, and generate the paper volumes. After the submission was created as a virtual document, the publishing tool generated all the navigational tools required for the submission, including the table of contents, cover pages, divider pages, and pagination. The submission was quality checked prior to submission.

In total, the NDA consisted of over 650 paper volumes and 1300 electronic volumes. The total review time from submission to final approval was 9 months. It was only through careful planning, and teamwork and the collaborative efforts of both the FDA and the company submission team that this became a success.

To discuss how Synergy Bioscience can help you, please contact us.

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