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Regulatory Electronic Submission Preparation, Filing and Approval for Drugs, Medical Devices and Combination Products based on eCTD and STED Standards

1. Service Description

We offer electronic regulatory submission preparation services in US and EU for Drugs, Medical Devices and Combination Products based on eCTD and STED Standards.

There will be productivity increase and cost savings of more than 80% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.

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2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

1. Process efficiency gains (people)
2. Less personnel requirements (people)
3. Infrastructure efficiency gains (systems)
4. Infrastructure validation and maintenance (systems)
5. Delivering quality products
6. Avoid regulatory noncompliance cost
7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size	Small	Medium	Large
$Savings	≥  20%	≥  60%	≥  80%
Annual Sales	≤ $100 million	$100 million < Sales ≤ $500 million	> $500 million
Number of Submissions	≤ 2 per year	2 < Sub ≤ 4 per year	> 4 per year

Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.

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3. Solution Approach

Regulatory electronic submission preparation service offered by us will

1. Minimize the Impact on Approval, Launch, and Time-to-Peak Sales
2. Implement Practical Approaches for Global CTD Submissions, Including Sample Submissions
3. Evaluate Regulatory Differences between US, EU, HC, and Japan
4. Prepare Applications in Multiple Submission Formats
5. Plan, Develop and Validate Software that Produces eCTD: Accounting for Title 21 CFR Part 11
6. Leverage the Efficiencies of XML Including Real World Examples
7. Comprehensive Technology Focus on eCTD Enablers for amendments and supplements
8. Submission Lifecycle Management using eCTD
9. Build eCTD into Core Document Management Processes

The FDA regulatory marketing applications for drugs, devices, and other submissions services offered are summarized in Table 1.0.

No	Regulatory Submission	Drug/Biologics	Device	Purpose
1	Clinical Trial Exemptions (Investigational Applications)	IND	IDE	Allowance to begin testing in humans
2	Marketing Applications	NDA, BLA, ANDA	PMA, PDP, 510(k)	Authorization to begin product marketing
3	Annual Reports, Adverse Event Reports and Promotional Materials	AR, AERS, Promotional Material	AR, AERS, Promotional Material	Post-marketing requirements

Table 1.0 United States Regulatory Marketing Applications Services

The European Union drugs and devices marketing application, and other submissions services offered are summarized in Table 2.0.

No	Regulatory Submission	Drug/Biologics	Device	Purpose
1	Clinical Trial Exemptions (Investigational Applications)	CTA Approval CA Approval	Notify Member States CA	Allowance to begin testing in humans
2	Marketing Applications	EMEA Approval · Initial applications · Supplementary information following validation · Variation submissions · Renewal submissions	Declaration of Conformity Approval by a Notified Body and CE Mark with Notified Body Number	Authorization to begin product marketing
3	Annual Reports, Adverse Event Reports and Promotional Materials	EMEA ·  Periodic Safety Update Reports (PSURs) ·  Follow-up measures (FUMs)	Inform Member State and CA. Member state to inform European Commission	Post-marketing requirements

Table 2.0 European Union Regulatory Marketing Applications

The FDA ESG supports following submissions in eCTD format.  Source FDA Electronic Submissions Gateway User Guide

Center	Submissions
CBER	AERS – Adverse Event Reports AERS Attachments BLA – Biologics License Application (eCTD and eBLA format) IDE – Investigational Device Exemption IND – Investigational New Drug Application (eCTD and eIND format) DMF – Drug Master File Promotional Materials Lot Distribution Data
CDER	AERS – Adverse Event Reports AERS Attachments ANDA – Abbreviated New Drug Application BLA – Biologics License Application NDA – New Drug Application IND – Investigational New Drug Application
CDRH	Adverse Events - Medical Device Reporting (MDR) Electronic Submissions IDE – Investigational Device Exemption 510(k) Notification PMA – Pre-market Approval Medical Device Reporting (MDR)
CVM	Electronic Submissions

Table 3.0.  List of Electronic Submissions Supported by the FDA ESG.  Source FDA Electronic Submissions Gateway User Guide.

We provide the standard template directory structure for all the modules as listed in Table 4.0 conforming to CTD specifications.

Module Name	Description	Folder Name
Module 1	Administrative Information and Prescribing Information (Regional Information)	m1
Module 2	Summaries of Quality, Non-clinical Overview, Clinical Overview, Non-clinical Summary, and Clinical Summary	m2
Module 3	Quality	m3
Module 4	Non Clinical Study Reports	m4
Module 5	Clinical Study Reports	m5

Table 4.0 CTD Module Name, Description, and Corresponding Electronic Folder Name

Figure 1 - The New Drug Development Process - Steps from Test Tube to New Drug Application Review - Source FDA

Figure 2 - Phases of Product Development, Years, Test Population, Purpose and Success Rate

Figure 3 - US FDA and EU Innovative IVD Marketing Approval Steps Summary

Figure 4 - Workflow Steps for Electronic Submissions

Figure 5 - Common Technical Documentation (CTD) Triangle

Figure 6 - Source and application of the STED (Source - GHTF STED, 2008, 7)

 

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4. Definitions

Common Technical Document (CTD): A harmonized format for a regulatory dossier that is considered acceptable in Japan, Europe, the United States and Canada.

eCTD: The electronic format of the ICH Common Technical Document

STED: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices.

What is the CE Mark?

The CE Mark is a product-conformity and labeling requirement for any regulated product (e.g. electrical equipment and medical devices) placed for sale in the European market. Placing the CE (Conformitè Europèenne) label on a product indicates that the product complies with the applicable European Directives (i.e. the European Union Law) relating to the health, safety, environment and consumer protection requirements of that product type.

The CE Mark Declaration of Conformity: The Declaration of Conformity is a document which defines the specific EU directive against which the CE Mark is being claimed. It can also detail the specific international standards to which the product has been tested and approved. The Declaration of Conformity is required to be available and to be reviewed by customs authorities and regulatory agents when shipped to an EU member state.

Product Licenses and Safety Certification: To support the claims described in the Declaration of Conformity, Company has to maintain product licenses and certifications granted by Notified Bodies.

Instrumentation, both the IVD and RUO products, are safety tested and certified for CE Marking by Notified bodies like TÜV America

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5. Applicable Laws, Regulations and Standards

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (2004). ICH M2 EWG – Electronic Common Technical Document Specification. http://estri.ich.org/eCTD/eCTD_Specification_v3_2.pdf
2.  Food and Drug Administration, CDRH. (2008). Guidance on Electronic Regulatory Submissions and Review (ERSR). http://www.fda.gov/cder/regulatory/ersr/default.htm
3. Global Harmonization Task Force (GHTF). (2008). Principles of Conformity Assessment for Medical Devices. http://www.ghtf.org/documents/sg1/SG1N40%202006-Conformity-Assessment-FINAL.pdf
4. Global Harmonization Task Force (GHTF). (2008). Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED). http://www.ghtf.org/documents/sg1/SG1-PD-N011-sted.pdf