Apothecaries

Contract research · Regulatory affairs · Since 1983

Clinical trials and product registration in India, handled end to end.

Apothecaries runs Phase II–IV clinical trials for global sponsors and takes drugs, devices, cosmetics and nutraceuticals through Indian regulation. One team owns your project, and you get a written report every Monday.

Send an RFP → Find your route to India

Offices  New York · Toronto · Frankfurt · New Delhi

Product registration in India

What are you bringing to India?

Each product type answers to a different regulator and set of rules. Pick yours to see where it sits and what we handle.

Regulator

CDSCO

The Central Drugs Standard Control Organisation, headed by the Drugs Controller General of India. State Licensing Authorities license manufacturing.

Rules that apply

  • Drugs and Cosmetics Act, 1940
  • Drugs Rules, 1945
  • New Drugs and Clinical Trials Rules, 2019

What we handle

  • Registration strategy and regulatory intelligence
  • Technical dossier writing and electronic publishing
  • Marketing authorisations, licence maintenance and renewals
  • In-country representation and regulatory liaison
  • Clinical trial applications and local studies
Not sure which?

Products that sit between categories are a speciality. Drug or food, drug or cosmetic, supplement or functional food: the classification decides the regulator, the rules and the timeline. 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.

Marketing authorisations

We can hold your marketing authorisations until you are ready to.

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.

300+
Marketing authorisations managed for pharma MNCs, across drugs, biologicals, devices, cosmetics, nutraceuticals and botanicals

Your virtual regulatory affairs office in New Delhi

Everything between your dossier and the market

Strategy

  • Registration strategy
  • Regulatory updates and intelligence
  • Regulatory classification of borderline products
  • Training for regulatory and marketing teams

Submissions

  • Technical dossier writing
  • Electronic dossier publication
  • Marketing authorisations
  • Maintaining licences and dossiers

In market

  • In-country representation and liaison
  • Review of claims, labels, package inserts and advertising
  • Consumer feedback management
  • GMP audits and training

Clinical research · ClinicalTug™

Your clinical trial project office in India

We work as a transparent extension of your team: from study design and documents to sites, enrolment, monitoring, data and the study report. We can initiate tens of sites in a matter of weeks and, in many studies, reach first patient in within 12 weeks.

Request a TechnoCommercial Offer →
  • Phase II–IV project managementEnd-to-end, from protocol to study report
  • Proof-of-concept trialsSwift, economical go/no-go decisions
  • Paediatric trialsNeonates to teenagers, including vaccines, hormones and dermatology
  • Medical device investigationsAll device classes, run to ISO 14155
  • Observational studiesRegistries, epidemiology, real-world outcomes, post-approval safety
  • In-home clinical trialsLicensed nurses and clinicians visit patients at home or work
  • Repurposing studiesProof of concept for repurposed drugs
  • Botanical, nutraceutical and cosmeceutical trialsEvidence for regulators and for credible marketing

CTPT

Your study, live

Our Clinical Trial Patient Tracker gives you 24×7 online access to project metrics.

Every Monday

A written report

A short, structured project report in your inbox every Monday morning.

Any time

Call the team

Talk to anyone on your study-dedicated team whenever you need to.

What a TechnoCommercial Offer covers

  • Study conceptualisation against your objectives
  • Protocols, CRFs and study documents
  • Regulatory affairs and approvals
  • Engaging labs, sites and investigators
  • Investigator meetings and staff training
  • Patient enrolment, placement and payments
  • Central pharmacy and logistics
  • Study hotlines and phone monitoring
  • AE/SAE and ADR information management
  • Monitoring, QA, QC and audit
  • Data management and query resolution
  • Biostatistics and study reports

Therapeutic experience

  • Oncology
  • Infectious diseases
  • Tuberculosis
  • Respiratory, incl. asthma & COPD
  • Cardiology
  • Endocrinology & diabetes
  • CNS, PNS & stroke
  • Psychiatry
  • Dermatology
  • Gynaecology
  • Pain management
  • Orthopaedics
  • Organ transplant
  • Vaccines
  • Haematology
  • Gastrointestinal
  • Genito-urinary
  • Dentistry
  • Surgery & wound healing
  • Burns
  • Paediatrics & geriatrics
  • Medical devices

Patient access, per year

Tens of thousands of patients recruited to date. Estimated patients we can access for enrolment in one year.

    Estimates of patients accessible for enrolment, not guaranteed enrolment. Actual numbers depend on your protocol's inclusion and exclusion criteria.

    Partnering

    Licensing partners and co-development capital

    Global licensing partnerships

    In-licensing and out-licensing for pharmaceuticals, biopharmaceuticals, medical devices, nutraceuticals, diagnostics and biomarkers. We find the right partner and manage the partnership end to end.

    • Partner identification and partnership design
    • Product co-development, including clinical development
    • ICH, US, EU and Japan dossiers for global applications
    • Production partnerships based on manufacturing audits
    • Market-specific labelling, distribution and logistics
    Send a non-confidential brief →

    Clinical co-development investment

    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, alongside devices, nutraceuticals and cosmeceuticals.

    • Part funding for late-stage clinical development
    • Clinical and regulatory strategy from our own teams
    • Market-access support across India, South-East Asia, the Middle East, the Far East and South America
    • A network of life-sciences professionals in the US, Europe, the Middle East, India and South-East Asia

    Send an executive summary and investor presentation to begin.

    Investments@Apothecaries.net →

    Start a project

    From RFP to first report

    1. Send an RFP or a briefKeep it non-confidential. If you need an NDA first, say so and we will send one.
    2. Receive a TechnoCommercial OfferHow our team will run the work, with scope, timeline and cost.
    3. Meet your dedicated teamOne team owns your study or registration from start to finish.
    4. Your first Monday reportWeekly reporting starts, with live access to study metrics.

    Prefer email? ReachUs@Apothecaries.net

    Investors: Investments@Apothecaries.net

    Send an RFP

    This opens an email to ReachUs@Apothecaries.net with your details filled in, ready to send.

    Non-confidential details only: indication, phase or registration type, target markets.