Nutrition · Clinical studies · Medical affairs · Writing

Evidence you can stand behind, from study design to the story you tell.

Tejhana Consulting is a life sciences consultancy for nutrition and health organisations. We design and run clinical studies, build the scientific case for your products, support your medical affairs team, and write the documents and content that carry your evidence to regulators, doctors and consumers.

Discuss your project Explore services Explore sample study protocols Read research & industry updates

Nutrition scienceformulation, evidence and claims

Clinical studiesfrom protocol to clinical study report

Medical affairsscientific support for your teams

Writing and contentregulatory, publications, HCP, consumer

About us

Science with a clear purpose

Tejhana Consulting LLP brings together nutrition science, clinical studies, medical affairs and scientific writing to help health and nutrition organisations build and communicate evidence.

Led by managing partner Dr Krathish Bopanna, our consultancy connects the questions behind a product with the studies and documents needed to answer them. Our work spans study design and conduct, evidence reviews, claims support, and communication for regulators, healthcare professionals and consumers.

We approach each engagement with a practical question: what evidence does this decision need? That question shapes the study, the analysis and the way the findings are explained.

Alongside this scientific work, the firm offers strategic advisory, mergers and acquisitions consulting and transaction support. Tejhana Consulting LLP was incorporated in 2019 and is registered with the Registrar of Companies, Bangalore. See our company details.

Our managing partner

Dr Krathish Bopanna

Dr Krathish Bopanna is a clinical pharmacologist, consultant and scientific writer with nearly thirty years of experience spanning pharmaceutical research and development, clinical trials and nutraceutical innovation. As managing partner of Tejhana Consulting LLP in Bengaluru, India, he advises on pharmacology, regulatory science, drug safety and scientific communications.

His career has included experience at AstraZeneca, as well as roles as CEO of Semler Research Center, Senior Vice President at Manipal Acunova and President of the Indian Society for Clinical Research (ISCR).

His research focuses on nutraceutical bioavailability, pharmacokinetics and translational pharmacology, including work on Coenzyme Q10 formulations, lutein–zeaxanthin delivery systems and phytonutrients. He has authored and co-authored peer-reviewed publications and collaborates on projects connecting laboratory findings with clinical applications.

Background drawn from his public ORCID profile: 0009-0009-4441-6319.

Discuss a project with Tejhana

Services

One team across the life of your evidence

Most products pass through four or five vendors on the way from idea to market. We cover each stage, so the science, the study and the message stay consistent.

Clinical studies

How we take a study from question to publication

Nutrition studies have their own challenges: modest effect sizes, dietary background noise, compliance and blinding. We plan for these from the first draft of the protocol.

Evidence and study question
We review what is already known, define the claim you want to support, and turn it into a testable primary endpoint.
Evidence summary and study concept
Protocol and design
Population, comparator, endpoints, biomarkers, dietary controls, sample size and statistical analysis plan.
Protocol, SAP, informed consent
Approvals and registration
Submission to the institutional ethics committee, and prospective registration on the Clinical Trials Registry of India.
IEC approval, CTRI number
Study conduct
Site selection, case report forms, participant diaries, monitoring and data management in line with Good Clinical Practice.
Clean, locked database
Analysis and reporting
Statistical analysis and a clinical study report that sets out results, safety and limitations clearly.
Clinical study report
Publication and use
Manuscript for a peer-reviewed journal, conference abstracts, and claim and communication material built on the results.
Paper, posters, claims dossier

See the study diagrams

Who we work with

Organisations that sell on science

Our clients need claims that hold up to regulators, clinicians and informed consumers.

Nutraceutical and functional food brands

Evidence planning, efficacy studies, label and claim support, and the content that explains your product to doctors and buyers.

Ingredient and blend manufacturers

Scientific dossiers, formulation support and clinical data that help your B2B customers choose and promote your ingredients.

Pharmaceutical and medical nutrition companies

Medical affairs support, regulatory and scientific writing, HCP education and publication planning.

Hospitals, research teams and startups

Protocol development, study management, statistical support and help turning results into publications.

Research & industry brief

Developments shaping nutrition & clinical research

A curated reading list on nutrition policy, FSSAI and CDSCO regulation, and clinical trial practice, with original sources for deeper reading.

Nutrition16 April 2026Advisory · India

FSSAI: ashwagandha leaves not permitted in health supplements

FSSAI reminded food businesses that only ashwagandha (Withania somnifera) root and root extracts are permitted under Schedule IV of the 2016 nutraceutical regulations. It cited safety concerns about reactive withanolides in the leaves, and the advisory followed a Ministry of Ayush direction issued the day before.

In practice Check ingredient specifications and supplier certificates for plant part. The Karnataka High Court has granted an interim stay to the companies that petitioned it; the advisory still applies to everyone else.

Read FSSAI advisories

Clinical research20 January 2026Amendment rules · India

CDSCO: NDCT (Amendment) Rules, 2026 introduce prior intimation for study material

Notified as G.S.R. 46(E), the amendment lets sponsors begin manufacturing new drugs and investigational products for clinical trials, BA/BE studies and testing once CDSCO acknowledges an online intimation on the SUGAM portal. Cytotoxic drugs, narcotics and psychotropics, sex hormones, beta-lactam antibiotics and biologics with live microorganisms still need prior permission, now with a 45-working-day review instead of 90.

In practice Can shorten study start-up. Trial approval, ethics committee review and CTRI registration are unchanged, and material made under intimation may only be used in the study.

Read the CDSCO gazette notifications

Clinical researchSeptember 2025Final guidance · United States

Good Clinical Practice: FDA issues ICH E6(R3) guidance

The revised guidance emphasizes quality by design, proportionate risk management and participant protection, while accommodating modern trial designs, data sources and technology.

In practice A useful reference when reviewing sponsor responsibilities, study oversight and quality planning.

Read the FDA guidance

Clinical research1 April 2025In force · India

CDSCO: CROs now need registration to run trials

Under the NDCT (Amendment) Rules, 2024 (G.S.R. 581(E)), contract research organisations must be registered with the Central Licensing Authority, applying on Form CT-07B, before they conduct clinical trials or BA/BE studies of new or investigational drugs in people.

In practice Confirm your CRO’s registration status when you qualify vendors for studies in India.

Read the CDSCO gazette notifications

Nutrition8 May 2025Proposal update · United States

Front-of-pack nutrition labels: FDA’s proposed approach

The FDA’s proposal describes a front-of-package Nutrition Info box showing saturated fat, sodium and added sugars as low, medium or high. Its May update extended the public comment period to 15 July 2025.

In practice The proposal and supporting consumer research offer insight into how people interpret nutrition information. This item describes a proposal, not a final requirement.

Read the FDA proposal overview

Nutrition19 December 2024Final rule announced · United States

Updated criteria for the “healthy” food label claim

The FDA announced revised criteria for the voluntary “healthy” claim. These combine qualifying food-group amounts with limits on added sugars, saturated fat and sodium.

In practice A reference for nutrition product teams assessing formulation and label claims for the U.S. market.

Read the FDA criteria

Clinical researchSeptember 2024Final guidance · United States

Planning clinical trials with decentralized elements

FDA guidance addresses trial activities outside traditional study sites, including telehealth, in-home visits and visits with local healthcare providers.

In practice A starting point for evaluating remote activities within a study’s participant experience and operational plan.

Read the FDA guidance

Open the news page

Manually curated. Dates refer to the source publication or update; this list is not a live news feed. These items cover developments in the United States and India; requirements in other markets differ. Follow the original sources for subsequent changes.

Standards we work to

Built on the guidelines your reviewers use

Every study and document we produce is planned against the Indian and international standards that will be used to judge it.

Standard	Issued by	What it covers	Where we apply it
ICH E6 GCP	ICH	Good Clinical Practice for designing, running and reporting trials	Protocols, monitoring, data management
National Ethical Guidelines	ICMR	Ethics of biomedical and health research involving people in India	Consent, ethics submissions, study conduct
CTRI	ICMR-NIMS	Clinical Trials Registry of India	Prospective registration of studies
NDCT Rules 2019	CDSCO	New Drugs and Clinical Trials Rules	Studies involving drugs or regulated products · Latest CDSCO update
FSSAI regulations	FSSAI	Nutraceuticals, health supplements, and advertising and claims	Product categories, labels and claims · Latest FSSAI update
CONSORT · ICMJE · GPP	Journal and industry bodies	Reporting of trials, authorship and publication practice	Manuscripts and publication plans

Questions

What clients ask first

Something else on your mind? Ask us in your enquiry.

Does a nutraceutical really need a clinical study?

Not always. Some claims can rest on existing published evidence for the ingredient. A study of your own product becomes valuable when you want a specific or stronger claim, need to show your formulation works, or want material that doctors will take seriously. We start with an evidence review so you only run a study when it adds value.

Can you take on just one part of a project?

Yes. Clients often come to us only for a protocol, a statistical analysis, a manuscript or a set of HCP materials. We can also take on the whole programme from evidence review to published paper.

Do nutrition studies need ethics approval and CTRI registration?

Research with human participants in India needs approval from a registered ethics committee under ICMR guidelines. We register studies prospectively on CTRI, because most journals require registration before the first participant is enrolled.

What kind of content do you create?

Scientific and regulatory documents, manuscripts and abstracts, medical education material for doctors and dietitians, product training for sales teams, and accurate, readable consumer content such as articles, leaflets and social posts.

How do you keep content accurate and compliant?

Every claim is referenced to its source, checked against the evidence and the applicable regulations, and reviewed before delivery. We write for the audience while keeping the science intact.

Start a project

Tell us what you are working on

Share a few details and we will come back with how we would approach it, what is involved, and what we need from you. Fill in the form to prepare your message, then send it to us by email.

krathishbopanna@tejhana.net