Regulatory Submissions and Report Publishing

Regulatory Operations groups have traditionally faced significant challenges in managing the submissions activities within life sciences organizations. Global differences and changes to Agency submissions requirements (yes, even in the era of the Common Technical Document and the eCTD), fluctuating internal submission schedules, coordination of vast amounts of scientific and medical information & data from a wide variety of internal contributors, while utilizing all-too-often disconnected IT tools that do not provide an adequate and tightly integrated view of the end-to-end process. Add to this scenario the need to speed new therapies to market while also turning around a variety of post approval submissions related to a portfolio of mature products. These persistent challenges continue to drive Regulatory Operations leads towards creative operating models that provide  workforce flexibility, greater efficiency, high quality submissions, and 24 by 7 follow-the-sun global operations.  Let us show you how we can help.

Business Need

• Most Regulatory Operations organizations begin their consideration of outsourcing as a result of budget or headcount restrictions or reductions, and often in the face of increased submission schedules (as companies expand into new and emerging markets). The focus has centered on what part of the operations could be shifted to lower cost markets and with limited risk, along with a better way to handle the peaks and valleys of submission schedules by better matching specific work to specific skill sets. As a result, report publishing and post approval submissions have emerged as logical candidates for outsourcing due to the nature and volume of this work.

How Can TAKE Solutions Help?

From our State-Of-The-Art Regulatory Processing Center in Chennai, India, TAKE offers document, report and submission level publishing for both simple and complex submission applications including life cycle management. In addition, TAKE also provides invaluable subject matter expertise in evolving electronic submissions standards, health authority specific guidelines and processes, through its experience gained from serving a wide range of customers and life sciences companies across the globe in their electronic submissions need.

Products/Services

• FDA submissions in electronic and paper formats
• Investigational Drug Submissions (IND)
• New Drug Applications (NDA)
• Abbreviated Drug Applications (ANDA)
• Drug Master File (DMF)
• European Drug Master File (EDMF) to EU National Authorities and Certificate of Suitability (COS) filings to EDQM
• Structure Product Labeling (SPL)
• NDC Labeler Code Request, Establishment Registration, Drug Listing Submissions to US FDA
• Establishing Electronic Submissions Gateway (ESG) for US FDA submissions
• European submissions in electronic (eCTD , NEES) and paper formats
• Market Authorization Applications to EMA and National Authorities
• Health Canada Submissions (IND, NDS, ANDS, DMF)