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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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.