DCGI Ethics Committee Accreditation Services

Navigating the process of obtaining accreditation for an Institutional Ethics Committee (IEC) from the Drug Controller General of India (DCGI) can be challenging. Our comprehensive three-step solution simplifies this journey, ensuring compliance and efficiency at every stage.

Step 1: Preparing for Application Submission:  We help institutions lay a strong foundation for their accreditation application with the following services:

Ethics Committee Formation:

• Assistance in identifying Ethics Committee members as per government guidelines.

Training Programs:

• Conducting one-day hands-on training workshops for Ethics Committee members to ensure proficiency in reviewing documents and understanding applicable guidelines.

Preparation of various regulatory annexures and other documents for application

Standard Operating Procedures (SOPs):

• Drafting SOPs for the Ethics Committee and Clinical Trial sites.

Hospital Profile Creation:

• Preparing the institution’s profile in line with government guidelines.

Step 2: Application Submission Assistance
Our support continues during the application submission process to ensure a seamless experience:

Online Account Creation:

• Assisting in creating an account on the DCGI’s official website.

Application Submission:

• Providing hands-on guidance or submitting the application on behalf of the institution.

Step 3: Post-Submission Support
Even after submission, our team remains dedicated to ensuring the application process is successful:

Query Resolution

• Addressing and responding to any queries raised by the government office.

Document Creation

• Preparing any additional documents requested during the review process.