At Trikonas, we support organizations across the Life Sciences ecosystem — from early-stage research and clinical development to commercial manufacturing and post-market compliance. Our scientific, regulatory, quality, and operational support services are tailored to the unique requirements of each sector we serve.
Biopharmaceutical
Our solutions help accelerate development timelines while ensuring global regulatory compliance. We support innovator and specialty pharma companies with:
- Regulatory submission documentation (IND, NDA, ANDA support)
- CMC documentation and technical writing
- GMP compliance support & audit readiness / GMP compliance and inspection readiness support
- Process validation & tech transfer
- QA/QC oversight
- Clinical documentation services
- Deviation, CAPA, and quality system documentation
- Batch record review & deviation documentation / Batch record review and manufacturing compliance support
Biotechnology
We understand the agility and precision biotech organizations require.
We work with emerging and established biotech companies in:
- Drug discovery documentation
- Preclinical research documentation
- IND-enabling documentation
- Scientific and technical writing services
- CMC documentation assistance
- Analytical method documentation
- Research data analysis & reporting
- Regulatory support documentation preparation
CROs -Contract Research Organizations
Our services enhance operational efficiency and regulatory readiness.
We collaborate with CROs by providing:
- Clinical trial documentation support
- Trial Master File (TMF) management
- Regulatory submission preparation
- Clinical Data review & quality checks
- Pharmacovigilance documentation
- Study start-up documentation support
CDMOs - Contract Development and Manufacturing Organizations
We help ensure seamless scale-up and compliant commercial production.
We assist CDMOs with:
- Process validation documentation
- Equipment qualification (IQ/OQ/PQ)
- Batch record review and Quality system support / documentation
- Quality management system support
- GMP compliance & audit readiness support
- Tech transfer documentation
Academic & Research Institutions
Our team helps translate research into real-world clinical and commercial impact.
We, research institutions for:
- Scientific manuscript preparation
- Grant writing and proposal support
- Research data analysis
- Translational research documentation
- Regulatory support for investigator-initiated studies
- Data analysis & technical reporting
Medical Devices
From concept to commercialization, we help maintain compliance and product integrity.
We support medical device organizations with:
- FDA 510(k) & PMA documentation
- ISO 13485 QMS implementation support
- Design controls & DHF documentation
- Risk management (ISO 14971) documentation
- Clinical evaluation & post-market support documentation
- CAPA & complaint handling support documentation
Hospitals & Clinical Networks
We understand the operational complexity of healthcare environments and deliver structured, compliant, and scalable support aligned with global regulatory standards. Our services include:
- Clinical research documentation support
- Study start-up & site activation assistance
- Institutional Review Board (IRB) documentation support/ preparation
- Trial Master File (TMF) management
- Clinical data review & quality checks
- Regulatory compliance support / documentation (GCP / FDA standards)
- SOP development & policy documentation
- Quality assurance & internal audit preparation
- Post-market clinical follow-up support (for device studies)
- Audit preparation & internal compliance reviews
