Standard Operating Procedure (SOP) for eCTD/CTD Dossier

The need for Standard Operating Procedures (SOPs) is enshrined in the 13th principle of GCP: That's because Standard Operating Procedure (SOP) are about decreasing variability in a process. DocentPharma eCTD dossier submissions templates and "standard operating procedure" are huge tools to increase efficiency, productivity, and consistency.

As We Decrease Procedural Variability, here are some most significant use of this tool.

1. To fulfill compliance requirements (by demonstrating how we translate GCP requirements into actions)
2. To communicate effectiveness instilling stakeholders' with confidencially investigators, patients, regulators in our competence to provide products or service that consistently fulfils requirements
3. To decrease error rate orimprove quality that improvement and change is tracked and documented.
4. To reduce unnecessary duplication of efforts and control information growth.

DocentPharma.com - eCTD dossier submissions Microsoft Word® templates are well-formatted and easy-to-use templates and also provides blueprint for text, graphics, styles and formatting of submission.

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Making of eCTD Dossier Preparation And Services
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FDA Panel Blog - DocentPharma

Pharmaceuticals brings its weight-loss drug lorcaserin in front of an advisory committee of the U.S. Food and Drug Administration today. DocentPharma is group of outside experts that the company has a weight-loss drug that is both effective and safe for the millions of obese Americans who can't seem to shed the pounds with diet and exercise alone.

In a review posted to the FDA's website, the agency's reviewers said only marginal weight loss for patients. The FDA also raised questions about the drug's safety and raised a concern about a potential cancer risk in animals. It's important to note that FDA drug reviews released ahead of advisory panel meetings are often sharply critical and sometimes do not accurately predict the ultimate vote of the panel's outside experts.

DocentPharma's enters the fray of an FDA advisory panel that Pharma Regulatory Services obsessed with drug safety and  unkind to obesity drugs. Eight experts siting on the same FDA advisory panel voted to withdraw weight-loss drug Meridia from the market, while another six panelists voted to restrict the drug's distribution.

Making of eCTD Dossier Preparation And Services

DocentPharma dossier can be used in Pharmaceutical Industries ideally for management of Dossier, Drug Master File, TAD and Product, create correspondence, manage departments documents for Legal, Human Resource, Accounts, RnD etc. The system can also be used to manage and validate the eCTD submissions.

eCTD (Electronic Common Technical Document) submissions are increasingly recommended by International drug regulatory agencies such as FDA, EMEA, Health Canada.

eCTD is a harmonized structure that facilitates reusable submission components across different global drug product submissions such as Abbreviated New Drug Application (ANDA) - US and Abbreviated New Drug Submission (ANDS) - Canada. Once an eCTD application is created for a specific drug and a specific regulatory agency (e.g., FDA), certain CTD modules can be reused for other regulatory agencies as well (Health Canada, etc.) with minimal to no changes.

DocentPharma offers the following eCTD services to ensure regulatory acceptable eCTD enabled submissions:

1. Preparation & Assist for Dossier assembly and compilation in eCTD Format (Module 1 - Regional, CTD Module 2 to Module 5)
2. Review & Validate eCTD Dossiers as per eCTD specification
3. Consultancy for Sample Submission/Pre-submission in eCTD Format
4. Consultation Services for Transition from Paper Based System to Electronic Common Technical Document (eCTD) System
5. Consultancy for navigation aid management including the table of contents, book marking and hyperlinks
6. Paper to electronic document conversion to provided searchable text based documents
7. Consultancy for Study Tagging Files (STF) for US FDA and Submission lifecycle management
8. Provides & Creates eCTD Templates for Module 1, Module 2 to Module 5 of US, Europe, Canada submission.
9. Electronic Submissions Gateway (ESG) setup and administration for electronic submissions