● 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
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 / Directives Changes and Announcements/Gazette notification
AREAS OF REGULATORY SERVICES
● Drugs
● Biologics
● Medical Devices
● Herbal, Nutraceuticals and Probiotics
Regulatory pathway defining
Technical gap analysis and review of documents
Dossier compilation
Application submission on portal
Review meetings with health authorities and regulatory liaison
Controlled correspondence, tracking and query response
Approval receipt
Regular study updates/notifications
Final study report notification
Different models
to meet diverse needs
to meet diverse needs
Insights &
Resources
Request For Proposal
We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Whatever your need, rope in COD Research experts to breeze through regulatory approvals and get your drug or device on the market soon.
