Electronic Submissions

The FDA is strongly encouraging the industry to move from paper to electronic submissions to increase review efficiency, minimize delays in routing and tracking, and reduce archiving costs. In recent years, it is promoting regulatory submissions in electronic format based on standards such as Electronic Common Technical Document (eCTD) for documents and Structured Product Labeling (SPL) which is FDA specific for package insert labeling, product listing, establishment registration and labeler code content.

Business Need

• Requirement for electronic submissions in eCTD format to the Centre for Drug Evaluation & Research (CDER-FDA) under Investigational New Drug (IND), New Drug (NDA), Generic Drug (ANDA), Active Pharmaceutical Ingredient (DMF) categories
• Encouragement to make electronic submissions in eCTD format to the Centre for Biologics (CBER-FDA) under IND and BLA categories
• Encouragement and in some cases mandatory requirement to make electronic submissions in eCTD format to the European Medical Evaluation Agency (EMEA) and European National Health Authorities under Market Authorization Applications (MAA) category
• Requirement for package insert labeling, NDC Labeler Code Request, Establishment Registration and Drug Listing submissions in SPL R4 format to the FDA
• Requirement for electronic submissions in eCTD format to Health Canada (HC) under Investigational New Drug (IND), New Drug Submission (NDS), Generic Drug (ANDS), Active Pharmaceutical Ingredient (DMF) categories
  

How Can TAKE Solutions Help?

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 EMEA and National Authorities
• Product Information Management (PIM) submissions
• Health Canada Submissions (IND, NDS, ANDS, DMF)