Clinical &
Regulatory
Excellence
Comprehensive solutions for Pharma, Biotech, and Medtech companies—from pre-clinical requirements to marketing authorization across global markets.
What We Do – Our Services
Comprehensive solutions across clinical research, regulatory affairs, and global compliance
Clinical Research Services
We provide comprehensive support for Phase I–IV Clinical Trials, PMS and IND studies, ensuring rigorous scientific standards and regulatory compliance throughout the clinical development journey.
Our study management expertise includes study design, site identification, patient recruitment, monitoring, safety reporting, and data management—transforming complex clinical data into submission-ready documentation.
Through expert medical writing, data management, safety reporting, and pharmacovigilance, we transform complex clinical data into clear, submission-ready documentation that meets global regulatory standards.
We specialize in serving Pharma, Biotech, Med-Tech, and Food-Tech companies with tailored solutions that address the unique challenges of each industry sector.
Regulatory Affairs & Submissions
Our dossier preparation services cover IND, NDA, ANDA, and DMF submissions for drugs, biologicals, and medical devices, ensuring comprehensive documentation that meets the highest regulatory standards.
We manage global submissions to major health authorities including US FDA, EMA, CDSCO, MHRA, and more-navigating complex regulatory landscapes with strategic precision and local expertise.
From labelling and packaging compliance to post-approval lifecycle management, we provide end-to-end support that keeps your products compliant and market-ready across all territories.
Our strategic planning services include regulatory strategy development, gap analysis, and global submission planning — helping you chart the most efficient path to market authorization.
Authorised Agent Support
As your India Authorised Agent, we provide complete support for regulatory representation in India, ensuring seamless compliance with CDSCO requirements and serving as your local regulatory presence for all interactions with Indian health authorities.
Our US Agent Support services offer comprehensive FDA agent services and regulatory representation in the United States, acting as your official US agent for medical device manufacturers and maintaining all required communications with the FDA on your behalf.
We handle all aspects of agent responsibilities including regulatory correspondence, compliance management, and market surveillance support-allowing you to focus on your core business while we manage your regulatory presence in these critical markets.
Why Choose CliniExperts
Your trusted partner for regulatory excellence and clinical success
Dual-Domain Expertise
Full-service capabilities in both Regulatory Consulting and Clinical Research Execution. We bridge the gap between regulatory strategy and operational excellence, delivering integrated solutions that accelerate your path to market.
Global Compliance
Deep knowledge of requirements from major regulators - US FDA, EMA, CDSCO and more. Our global regulatory intelligence ensures your submissions meet the highest standards across all target markets, reducing delays and maximizing approval success.
Proven Track Record
Trusted by leading Pharma, Biotech, Med-Tech and Food-Tech firms for complex submissions and global trial execution. Our portfolio of successful regulatory approvals and clinical studies speaks to our commitment to excellence and client success.
200+
Successful Submissions50+
Global Markets15+
Years Experience100%
Client SatisfactionGlobal Market Access
Strategic entry solutions for worldwide markets
India
CDSCO regulatory pathway and market entry strategy
United States
FDA submissions and US market access solutions
United Kingdom
MHRA compliance and UK market authorization
European Union
EMA submissions and EU centralized procedures
GCC Countries
Gulf region regulatory strategy and registrations
APAC Region
Asia-Pacific market access and regulatory support