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We provide all types of high-quality forms and templates across many different fields, including: regulatory guidance, manufacturing and quality compliance regulations, approval process, and relevant Best Practices (GMP, GDP, GCP, GLP, GVP, GPP, GTP, …) in drugs, medical devices, combination products, food & food ingredients, dietary supplements, and complimentary & alternative medicine. We cover theses subject globally (North America, European Union, Latin America, Asia Pacific, Africa, and Middle East). Simply search by category then browse to find the document you need. New templates are added on a daily basis so please check often.
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This 31-page GLP inspection template is intended to assist you in the process of auditing for GLP compliance.
This 21-page Investigator’s Brochure Template is intended to assist you in the process of drafting an Investigator’s Brochure (IB) for Devices, based on ICH Topic E 6 (R1) “Guideline for Good Clinical Practice.”
This 33-page Investigator’s Brochure Template is intended to assist you in the process of drafting an Investigator’s brochure for drugs based on ICH Topic E 6 (R1) “Guideline for Good Clinical Practice”.
This 13-page template is intended to assist you in the process of creating a medical monitoring plan for the clinical trials.
This is a 2-page MS Word Standard Operating Procedure Template to be used as a starting point for preparing a standard SOP. We have included a proposed structure for an SOP as well as draft language and other guidance to assist you in creating a good SOP. We have saved this template in different formats (.docx, .dotm, .dotx, .docm, .doc, and .dot) to make sure it is compatible with all systems.