REGULATORY SUPPORT

Regulatory support services at CROM includes

• Prepare & Submit Regulatory dossiers as per regulatory guidelines.

• Liaising & Following up with Regulatory authorities.

• Consultation of Drug & Device Regulations.

• Global Clinical Trials - Regulatory Submissions

• Comprehensive gap analysis of regulatory data

• Electronic Common Technical Document (eCTD) services , publishing and regulatory authority submission management

• NCEs, NMEs, devices, generics, biologics, biosimilars and drug-device combination