Trikona Solutions
Trikona Solutions Inc., headquartered in the United States, is a forward-looking technology and life sciences services firm specializing in Regulatory, IT, and Artificial Intelligence solutions.
Services
Why Choose Us
Regulatory-First Execution
We align our services with: • FDA regulatory expectations • ICH guidelines • GMP, GCP, and GLP frameworks • ISO standards (including ISO 13485 and ISO 14971) Our work is structured to withstand regulatory scrutiny, inspection review, and audit evaluation
Structured Documentation Governance
In regulated industries, documentation is strategic. We implement: • Controlled documentation frameworks • Risk-based quality thinking • Gap analysis and remediation planning • Audit-readiness alignment • Clear traceability and version discipline Our methodology strengthens compliance posture while reducing regulatory risk.
Integrated Lifecycle Support
We support organizations across the full development continuum: • Preclinical and IND-enabling documentation • Clinical operations and TMF support • Regulatory submission preparation • Manufacturing and validation documentation • Post-market quality and compliance oversight This integrated capability ensures continuity, consistency, and alignment across functional areas.
A Partner in Regulatory Confidence
Trikonas is committed to delivering technically sound, disciplined, and scientifically rigorous service solutions that help organizations move forward with confidence in complex regulatory landscapes.
Precision Without Operational Disruption
We integrate seamlessly into sponsor, CRO, CDMO, MedTech, and hospital frameworks without disrupting internal operations.
Our engagement model emphasizes:
• Scalable support
• Structured onboarding
• Confidential, professional collaboration
• Clear communication and defined deliverables
We strengthen internal teams rather than replace them.
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Compliance-Driven Mindset
We understand that regulatory risk is operational risk. Our services are built to: • Enhance inspection readiness • Improve documentation defensibility • Strengthen quality systems • Reduce remediation exposure • Support long-term regulatory positioning
Industries
Biopharmaceutical
We support biopharmaceutical companies with compliant, end-to-end solutions across regulatory, clinical, and manufacturing functions. Our services strengthen documentation integrity, audit readiness, and operational efficiency. Trikonas enables faster development while maintaining scientific and regulatory excellence.
Biotechnology
We partner with biotechnology companies advancing innovative therapies and research programs. Our expertise supports preclinical documentation, CMC development, and regulatory submissions. Trikonas ensures scientific precision and compliance across every stage of biotech innovation.
CROs
We collaborate with CROs to enhance clinical operations, documentation accuracy, and regulatory compliance. Our services include TMF management, study start-up support, and submission-ready documentation. Trikonas strengthens quality and efficiency across global clinical research programs.
CDMOs
We partner with CDMOs to strengthen quality systems, process documentation, and regulatory compliance. Our services support GMP operations, validation, and tech transfer activities. Trikonas helps ensure consistent, compliant, and efficient manufacturing outcomes.
Medical Devices
We support medical device companies across design, quality, and regulatory functions. Our expertise covers ISO 13485 compliance, FDA 510(k) documentation, and risk management. Trikonas ensures product safety, regulatory readiness, and lifecycle quality excellence.
Research Institutes
We collaborate with research institutes to advance scientific discovery and translational research. Our services include documentation support, data analysis, and regulatory compliance assistance. Trikonas ensures research integrity, accuracy, and alignment with global scientific standards.
Hospitals & Clinical Networks
We partner with hospitals and clinical networks to support research operations and regulatory compliance. Our expertise spans clinical documentation, IRB submissions, and quality management systems. Trikonas helps ensure data integrity, patient safety, and adherence to GCP and FDA standards.
3 sides of Trikona
Empower
Empowerment is the cornerstone of our partnership. Your success is our success, and we're here to support you every step of the way.
Educate
Empowerment begins with knowledge. At Trikona Solutions, we equip you with the insights to navigate the complexities of the industry confidently.
Execute
Execution is the heartbeat of success. Trikona Solutions is your reliable partner in turning visions into reality.
OUR PARTNER BRANDS
Apart from in-house brands, House of Spices (India) Inc.
is also one of the largest distributors of South Asian brands in North America.
