Speeding The Path To Regulatory Approval In The Era Of Electronic Submissions

When a pharmaceutical company wants its new drug on the market, it must first submit mountains of paperwork to regulatory agencies like the US Food & Drug Administration (FDA)—most of it scientific articles describing the drug’s properties. Gathering these articles can be time-consuming, expensive and downright exhausting. And if the company opts to submit them all electronically, there’s another hurdle to clear: the regulatory agency wants all articles in the electronic Common Technical Document (eCTD) format. What’s an overworked pharma company staffer to do? Answer: turn to a dedicated professional document service for help. Such a service can speed the drug approval process and help companies save time and money.

The eCTD format was chosen partly because it makes copying, pasting, viewing, printing and annotating documents much easier. Yet making sure the documents are formatted properly can be a complex job involving a great deal of management and juggling. Since the eCTD format is so specialized, last-minute requests for formatted articles can delay the drug approval process. “When the FDA receives badly formatted documents, they can stop the drug review until the pharmaceutical company supplies them with corrected versions—a situation that can cost huge sums in lost revenue by impacting the time to market and the stock price,” says Peter Derycz, CEO of Derycz Scientific, a content-repurposing company specializing in the life science industry.

According to Derycz, “the use of a dedicated eCTD document service, such as that offered by our subsidiary Reprints Desk, Inc. can provide valuable aid in this regard.” Such a service can retrieve documents, either singly or in batches, in as little as a couple of hours. It can ensure that the documents are formatted properly, and provide a dedicated project manager to oversee the entire process.

When Company X needs 12 documents on drug Y, it contacts the document service and specifies the documents it needs. The document service then retrieves those documents, pays copyright royalties to the documents’ publishers, and formats the documents according to the eCTD standard. This arrangement is highly economical. When paper versions of documents are used, they are usually prepared just prior to submission, inviting delays; with electronic submission, documents can be prepared continuously from the start of clinical trials, potentially saving considerable time and money.

Anyone skeptical of taking a traditional in-house task and assigning it to an outside service should consider the advantages. An independent document service will have expertise in managing information and electronic resources and be thoroughly familiar with the eCTD format and current copyright laws.

The pros of sharing the eCTD formatting task with a professional document preparation service seem clear. The best step a company can take to speed its way through the regulatory approval process is for it to contact a supplier like Reprints Desk to find a solution that will benefit the company, its financing and ultimately the people who will reap the benefits of its drug.

Forward-Looking Statements
As a cautionary note to investors, certain matters discussed in this press release may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such matters involve risks and uncertainties that may cause actual results to differ materially, including the following: changes in economic conditions; general competitive factors; acceptance of the Company’s products in the market; the Company’s success in technology and product development; the Company’s ability to execute its business model and strategic plans; and all the risks and related information described from time to time in the Company’s SEC filings, including the financial statements and related information contained in the Company’s SEC Filing. The Company assumes no obligation to update the information in this release.