REGULATORY AFFAIRS

We provide scientific and regulatory consulting support with well-defined regulatory strategies and roadmaps for regional requirements.

• Team of dedicated, experienced and committed people offers unmatched scientific, regulatory and operational expertise with a thorough review.
• Operating through the most updated Regional Regulatory Requirements Database (RRRD) maintained by our experts.
• Well-versed with various regulatory portals and country-specific regulations, including USFDA, EMEA, and CDSCO (Indian National Regulatory Authority).

USFDA

(United States Food and Drug Administration)

• Research and Commercial IND
• ANDA
• NDA
• BLA
• Expedited Programs (including Fast Track, Accelerated Approval, Breakthrough Therapy, and PRIME-Priority Medicines)
• Orphan Drug Designations – Applications for Rare Diseases
• Protocol Registration and Results System (ClinicalTrials.gov)

EU

• Clinical trial application for various pathways like nationalized procedure, mutual – recognition procedure, decentralized and centralized procedure
• Clinical Trials Information System – CTIS (new regulation)

CDSCO

• Clinical Trial Approval (CTNOC) in India
• Investigational Product/Device and Biological Samples import and export permissions
• Support for Subject Expert Committee (SEC meeting) in case of complex or specific clinical trials
• Clinical Trials Registry – India (CTRI)
• Safety reporting as per national regulations through our safety experts

General

• Support the sponsor for briefing documents review in a scientific way
• Regulatory Intelligence: Active updates on Legislation/Regulation/Guidelines/Directive Changes and Announcements/Gazette Notification

AREAS OF REGULATORY SERVICES

• Drugs
• Biologics
• Medical Devices
• Herbal, Nutraceuticals and Probiotics