Datafarm Regulatory Services

In addition to providing software solutions for facilitating eSubmissions, Datafarm offers three types of services to support regulatory submissions worldwide: eSUB Outsourcing, eSUB Enabling and eSUB In-Sourcing.

eSUB Outsourcing

The experienced eSUB Outsourcing team combines skills and technology to transform paper-based submissions into fully compliant eSubmissions. Whether companies require help transforming legacy data into an eSubmission or assistance in compiling an eSubmission, the Datafarm eSUB Outsourcing team is a very capable and efficient option.

eSUB Outsourcing services can be placed into three Service Categories:

• Submission Component Preparation
  

• Scanning Services
• MS-word Source Document Rendering
• MS-word Source Document Formatting
• PDF Publishing
• Document Quality Control Activities
• SPL & PLR Labeling Conversion Services
• PIM Labeling Services
• FDA Submission Data (CRT) Preparation Services
• CDISC/FDA Submission Data Conversion Services

• eSubmission Assembly & Paper Publishing

• Submission Quality Control Activities
• eCTD Compilation
• XML Validation Services
• Life Cycle Management
• Paper Dossier Services
• Work Practices Kit
• eCTD Submission Tracking Checklist

• Consultation, Training & Education

• eCTD Guidance Consultation
• Regional Regulatory Guidance Consultation
• Submission Readiness Assessment
• Submission Component Templates
• eCTD Infrastructure Readiness Gap Analysis
• Submission Inventory Services
• Strategic eSubmission/eCTD Assessment Service
  
  

After receiving client submission documents (word or PDF) and data via secured FTP, Web Portal or CD/DVD, the Global Regulatory Submission Services Group sends back a CD/DVD containing the completed electronic submission which can then be sent to the Regulatory authority. Additionally, using Datafarm’s web-based submission viewer, clients can access their submission within their organization during the assembly process. For FDA submissions, Datafarm can leverage the FDA ESG gateway to expedite the delivery of submissions.

eSUB Outsourcing is ideal for clients who need to file electronic submissions but currently lack the infrastructure or resources to fully support the activity. It is also an excellent option for peak workloads, urgent requirements such as filing an expedited or fast-track submission and handling unfamiliar submission formats.

eSUB Enabling

eSUB Enabling allows companies to develop the infrastructure and in-house capabilities necessary for submitting electronic submissions with the end-goal of self-sufficiency.

As part of this collaboration, Datafarm provides the necessary resources to assist companies in publishing and compiling an eCTD and, at the same time, provide expert on-the-job training. eSUB Enabling services include, but are not limited to:

• eCTD infrastructure development (coordinated by the Datafarm Technical Services Group)

• Software installation/validation
• End-user training

• Collaboration on standard operating procedures

• Authoring
• Publishing
• Legacy document conversion
• Quality checking

• Knowledge transfer for best practices
• On-the-job training

Combining Datafarm’s technology and regulatory expertise provides the latest compliant software and superior regulatory support to guide clients through submissions.

eSUB In-Sourcing

Combining aspects of eSUB Outsourcing and eSUB Enabling, the eSUB In-Sourcing approach supplements a company’s internal resources with Datafarm experts in a collaborative effort. In-Sourcing focuses on achieving a compliant eSubmission rather than on knowledge transfer and, as such, does not offer “on-the-job-training.” However, client regulatory personnel can anticipate an increased understanding of the eCTD electronic submission process by project completion.

Services in the eSUB In-Sourcing option include, but are not limited to:

• Augmenting existing client resources
• Assigning activities supporting electronic submission project
• Consultation on technical and validation issues pertaining to electronic submissions
• Guidance and support for interpreting current ICH, Regional specification and guidance documents

eSUB In-Sourcing provides additional resources and expertise when required.

Global Regulatory Submissions Group (GRSG)

Datafarm’s mission is to partner with clients to achieve mutual success, providing Global Regulatory Submission Services that support both:

• companies seeking the flexibility of leveraging an outsourced partner to address their eSubmission and paper publishing needs and
• companies with established eSubmission capabilities looking for additional resource support to address peak workloads or other specific eSubmission or paper publishing goals.

The Datafarm Regulatory Services Group (RSG) experts are available to work with client teams to create the optimum solution for every unique situation. As industry experts in regulatory submissions (both electronic and paper), Datafarm’s RSG provides technical competency with its industry recognized solutions together with extensive experience working with large and small Life Sciences companies.

The Track Record Speaks For Itself

The Datafarm team has already produced and assisted with the assembly of hundreds of electronic submissions worldwide. Datafarm possesses experience with all US submission types (NDA, BLA, ANDA, IND, DMF, etc), all EU procedures (Centralized, Decentralized, Mutual Recognition, and National) and EU submission types (Original, Variations, FUM, PSUR, etc.), all Health Canada submission types (NDS, sNDS, Clarifaxes, etc.) and Japanese MHLW submission types delivered in eCTD format.

Datafarm’s Regulatory Services organization has provided services for over 100 client companies. Clients include Top Tier Pharma/BioTech, Mid-Level Pharma/BioTech and Emerging Pharma/BioTech companies.

Creating Partnership for Successful eSubmissions

Whether Datafarm simply supplements existing resources at peak times, helps personnel acquire knowledge or provides complete electronic submissions, the Regulatory Services Group can help increase efficiency, reduce the cost of developing an infrastructure and system architecture, and minimize overhead.
In a stringent and exacting regulatory environment, Datafarm offers access to recognized industry specialists that, when combined with proven software solutions, delivers compliant, timely and effective electronic submissions. Datafarm’s Submissions Alliance services have helped many companies create and maintain the eCTD life cycle for their electronic dossiers.