Apothecaries runs Phase II–IV clinical trials for global sponsors and takes drugs, devices, cosmetics and nutraceuticals through Indian regulation. One dedicated team owns your project and reports to you every Monday.
From the first protocol or dossier to a product in market, with one team accountable for the whole route.
Phase II–IV project management, proof-of-concept, paediatric, device and in-home trials.
Learn moreRegistration strategy, dossiers, marketing authorisations and in-country representation.
Learn moreIn- and out-licensing partners for drugs, devices, nutraceuticals and diagnostics.
Learn moreCo-development capital for Phase II/III-ready assets, orphan drugs and 505(b)(2)s.
Learn more
Apothecaries began as a pharmaceutical consultancy in 1983 and has provided contract clinical research since 1993. We work as the virtual regulatory affairs and clinical project office in New Delhi for global blue-chip sponsors and emerging companies in the US, EU, Japan and Australia.
Each product type answers to a different regulator and set of rules. Pick yours to see where it sits and what we handle.
CDSCO
The Central Drugs Standard Control Organisation, headed by the Drugs Controller General of India. State Licensing Authorities license manufacturing.
CDSCO & State Licensing Authorities
Who licenses a device depends on its risk class and whether it is imported or made in India.
CDSCO
CDSCO registers imported cosmetics. State Licensing Authorities license manufacture in India.
FSSAI
The Food Safety and Standards Authority of India covers health supplements, nutraceuticals, functional foods and foods for special medical purposes.
State Licensing Authorities
Working within the framework set by the Ministry of Ayush.
Not sure which category you are in? Products between drug and food, drug and cosmetic, or supplement and functional food are a speciality. Send us the formulation and intended claims and we will tell you where it belongs.
A starting map, not legal advice. The right route depends on your product's formulation, claims and origin.
No Indian entity yet? Apothecaries holds the authorisation as custodian while the product rights and IP stay with you. When your local entity or licensee is ready, we transfer it.
ClinicalTug™ project management
We work as a transparent extension of your team: study design and documents, sites and investigators, enrolment, monitoring, data and the study report. We can initiate tens of sites in a matter of weeks.
Request a TechnoCommercial OfferEnd to end, from study concept and protocol to the final report.
Swift, economical studies for a clear go/no-go decision.
Neonates to teenagers, handled with the care the scrutiny demands.
Clinical investigations for all device classes, run to ISO 14155.
Patient registries, epidemiology and post-approval safety surveillance.
Licensed nurses and clinicians visit patients at home or work.
Evidence for regulators and for credible marketing claims.
From small proof-of-concept studies to large trials on botanicals.
Send us an RFP and we will set out how our team runs every part of the study.
Estimated patients we can access for enrolment in one year, by indication.
No listed estimate for that indication. Send us your protocol's inclusion criteria and we will assess access for you.
Estimates of patients accessible for enrolment, not guaranteed enrolment. Actual numbers depend on your protocol's inclusion and exclusion criteria.
Keep it non-confidential. If you need an NDA first, say so and we will send one.
How our team will run the work, with scope, timeline and cost.
One dedicated team owns your study or registration from start to finish.
Weekly reporting begins, with live access to study metrics.
In-licensing and out-licensing for pharmaceuticals, biopharmaceuticals, medical devices, nutraceuticals, diagnostics and biomarkers.
For companies at the threshold of Phase II or III, or ready to commercialise. Orphan drugs, 505(b)(2) candidates and botanicals particularly interest us.
Send an executive summary and investor presentation to begin.
Email Investments@Apothecaries.netTell us what you are planning. You will get a TechnoCommercial Offer setting out exactly how our team would run it.
Send a non-confidential outline of your trial, product or partnership. We reply with a TechnoCommercial Offer.
