- Regulatory and compliance
- Clinical trials
- Pharmacovigilance (drug safety)
- Labs
From lab to launch, and every step after.
We help pharma, medtech, nutraceutical and FMCG companies take products to market and keep them there. Regulatory clearance and compliance audits. Clinical trials. Accredited lab testing. Drug safety. Real-world evidence and market entry.
- CDSCO-registered CRO (Reg. No. CRO/KA/2025/000030)
- ISO/IEC 17025 lab (Certificate No. UK-02-VS-04215)
- ISO 9001:2015 certified
TrialGuna in numbers
- 150+clinical studies supported
- 40+partner hospitals
- 10countries served
- 50+clinical trial sites
Reporting a side effect from a medicine or device? See how to report →
Companies we have worked with
See all 40 clients →
Partner hospitals and research sites
See all 62 sites →
What we do
Ten services, from first idea to market
Our core services are regulatory affairs, pharmacovigilance (drug safety) and clinical trials. Use one service or several. When you use more than one, our teams share the work. You deal with fewer vendors and fewer handovers.
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Regulatory and compliance
Regulatory affairs
We plan your route to approval and prepare the dossier: the full set of documents a regulator reviews. We file with CDSCO in India, the US FDA, and under EU MDR. We also run compliance audits, so you are ready for inspection.
Learn more about Regulatory affairs → -
Drug safety
Pharmacovigilance
Pharmacovigilance means watching for side effects once a product is in use. We assess safety reports, spot new risks early and write the reports regulators ask for.
Learn more about Pharmacovigilance → -
Clinical trials
Clinical trials (CRO)
We run clinical trials for product companies. We write the study plan, set up hospital sites, check the data and analyse the results.
Learn more about Clinical trials (CRO) → -
Science and labs
Accredited labs
We test products and packaging in the lab. We run shelf-life studies, shipping tests and label checks.
Learn more about Accredited labs → -
Science and labs
Microbiology studies
We test how well products stop germs, check that sterile products are free of microbes, and test preservatives.
Learn more about Microbiology studies → -
Science and labs
Human factors and packaging
We check that real people can use a product safely. We also test whether packs are hard for children to open.
Learn more about Human factors and packaging → -
Market
Real-world evidence
What we learn from patients in everyday care, outside a trial. We work with hospitals on registries and study data.
Learn more about Real-world evidence → -
Market
Market access
How your product reaches buyers. We plan the launch, find distributors and match the plan to your approvals.
Learn more about Market access → -
Market
Innovation and strategy
For start-ups, labs and companies with a new idea. We turn it into a plan: the science, the approvals and the evidence you need.
Learn more about Innovation and strategy → -
Science and labs
Organoids and NAMs
Organoids are tiny 3D tissues grown from human cells. They are one kind of NAM (new approach method): a way to test that can reduce animal testing.
In collaboration with Tissue Zen Learn more about Organoids and NAMs →
How we work
Five stages, from idea to market
You can start at any stage. Use one stage, a few, or all five. When one stage ends, our next team picks up the work. You do not have to manage the handover.
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Stage 1: Idea
Test the idea, check it can work, and design the studies.
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Stage 2: Lab testing
Accredited lab tests, microbiology and shelf-life studies.
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Stage 3: Clinical trials and safety
Run the trials and track side effects.
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Stage 4: Approval
Prepare and file the dossier with CDSCO, the US FDA or under EU MDR.
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Stage 5: Launch and after
Bring the product to market and gather evidence from everyday use.
Where are you now?
Help before launch, during launch and after
Find the phase your product is in. Each one shows the services that help, and what we do for you then.
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Phase 1
Before launch
You have an idea or a product, but no approval yet.
- Innovation and strategyTurn the idea into a plan: the science, the approvals and the evidence you need.
- Organoids and NAMsGet early safety and efficacy data from human cells.
- Accredited labsTest stability, packaging and shipping.
- Microbiology studiesTest preservatives, sterility and germ control.
- Human factors and packagingCheck people can use it safely, and that packs keep children out.
- Clinical trials (CRO)Run the studies in people that prove it is safe and works.
- Regulatory affairsPrepare the dossier and get the approval.
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Phase 2
During go-to-market
Approval is in sight, or done. Now you need to reach buyers. (Go-to-market means how a product reaches the people who buy it.)
- Market accessPlan the launch, pricing and distributors, and match them to your approvals.
- Regulatory affairsCheck labels, and get the licences you need to sell or export.
- Compliance auditsCheck you are ready for inspection before you sell.
- PharmacovigilanceSet up your drug safety system before the first sale.
- Accredited labsRelease each batch with the right tests.
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Phase 3
After launch
The product is on the market. Now you must keep it safe, keep it approved, and learn from real use.
- PharmacovigilanceTrack side effects and send the reports regulators ask for.
- Real-world evidenceLearn how the product works in everyday care.
- Regulatory affairsHandle changes, renewals and inspections, and stay audit-ready.
- Compliance auditsStay ready for inspections and client audits.
- Clinical trials (CRO)Run studies after approval, when regulators ask for them.
Who we work with
Product companies, hospitals and research partners
We work with the companies that make health products. We also work with the hospitals and research groups that help us test them.
- Pharma
- MedTech
- FMCG
- Nutraceuticals
- Hospitals
- Universities
- AI health
- Start-ups
One contract
Sign one contract for regulatory, clinical, lab and safety work. Fewer handovers mean fewer gaps.
Steps run side by side
Where the rules allow, our teams run steps at the same time. How much time this saves depends on the product.
Records an inspector can check
We follow written procedures. Our study data systems come from vendors who validate them for 21 CFR Part 11, the US rule for electronic records. We keep their evidence on file.
Tests built on human cells
Organoids are grown from human cells. They can show effects that animal tests may miss. We run these tests in collaboration with Tissue Zen.
One plan for many markets
We file with CDSCO, the US FDA and under EU MDR. We plan your documents so parts can be reused in each market.
Research partners
We work with research institutes and 40+ partner hospitals, including IISc, C-CAMP and AIC-CCMB.
Research partners and collaborators
Also: .
Industries
Industries we work with
Each industry has its own rules. We plan the work around the rules your product must meet.
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Not sure your product fits?
Tell us what it is. We will tell you which rules apply and how we can help.
Ask us → - Pharmaceuticals
- Medical devices and MedTech
- Food and FMCG
- Nutraceuticals
- Biotechnology
- Biologics and vaccines
- AI in healthcare
- Universities and research
- Hospitals
- Community healthcare
Our vision and mission
Our vision
A healthier world, where every patient's experience helps shape the next breakthrough.
Our mission
We listen to patients and work with our customers to turn what we learn into safe, science-led products that improve lives.
Start a conversation
Talk to a regulatory or clinical lead.
Tell us about your medicine, device or product. We will suggest a route to approval in each market you want to reach. We will also tell you which studies you need.
Contact us
Visit us in Bengaluru
467, 1st Main Road, Royal County, 8th Phase,
Gottigere, Kothnur, Bengaluru 560083
Call us
+91 88671 25414Mon – Fri, 9:30 am – 6:30 pm IST
Message us on WhatsApp → (opens in a new tab)