Since 2012 · Mumbai, India

From global innovation to India's next breakthrough

We take pioneering MedTech companies from first consultation to sustained growth in India — guiding you through every gateway: clinical study, commercial launch, and local manufacturing. One partner, the entire climb.

Global Innovators Indical Consultation 1 · Clinical Study 2 · Commercial Launch 3 · Local Manufacturing Sustained Growth & Profitability
$18B+
India MedTech market in 2026, ~8% CAGR
12x
Lower operating & labour cost vs. USA
8.2%
Share of global economy (PPP)
3–5×
Lower clinical trial costs vs. US/EU
Top 20
Global medical device market · #4 in Asia
Who We Are

India's most comprehensive MedTech partner

Founded
2012
Headquartered
Mumbai, India
Majority Shareholder
Partisan Healthcare Advisory (Irvine, CA)
Specialties
All Medical Device Specialties
Network
India, Middle East & Africa
Global Access
Via Partisan's Network — USA · Europe · LatAm

Indical MedSurg Pvt Ltd is the India-based MedTech commercialisation company majority-owned by Partisan Healthcare Advisory, its major holding company. Indical's own operations are focused on India, the Middle East and Africa — and through Partisan, Indical clients gain access to Partisan's wider global network across the USA, Europe, and Latin America.

Since our founding in 2012, we have been the trusted single-window partner for foreign MedTech companies entering India — combining regulatory expertise, clinical research, local manufacturing, and distribution under one roof. Thirteen-plus years navigating India's complex MedTech regulatory landscape means global standards, deep local expertise, and real commercial results.

The only advisory in India combining CRO + Regulatory + Manufacturing + Distribution under one roof
We don't just process paperwork — we serve as strategic advisors, bringing global executive experience to optimise revenue and the bottom line
Specialising in emerging markets, where friction is highest and ROI potential is unmatched
Our Four Service Pillars

One partner, the entire pathway to market

Everything a foreign MedTech company needs to succeed in India — a product's actual route from first study to first sale, handled end to end.

01 / Clinical Research (CRO)

Full-service CRO

FDA projects, fast IRB approvals, 40+ investigator sites, expert data management and medical writing — from First-in-Human studies to registries.

#1 Revenue Driver
02 / Market Entry & Regulatory

Authorised Indian Representative

MD-15 import licensing, CDSCO submissions, complete regulatory strategy, dossier preparation, and local entity formation.

#2 Key Differentiator
03 / Local Manufacturing

Strategic manufacturing

Partnership with Dolphin LifeScience (US FDA registered, ISO certified) — full ETO sterilisation and ISO Class 7 cleanroom production.

#3 Cost Advantage
04 / Distribution & Sales

Pan-India commercial channel

Experienced sales force, KOL relationships, and Partisan's global network activate the market once approved.

#4 Market Reach

Clinical Research — the numbers

67+
FDA projects
40+
Investigator sites
5+
Registry studies
3,500+
Registry patients
89%
Registry compliance (vs. 67% industry avg.)
3 mo
Approval process (vs. 6 mo industry avg.)
4 mo
Review process (vs. 9 mo industry avg.)
3–5×
Lower trial costs vs. US/EU

Your regulatory pathway into India

Option A

Standard Pathway

12–18 months
  • Set up Indian legal entity yourself
  • MD-15 import licence under own name
  • Build own sales infrastructure
  • Higher upfront cost & longer timeline
Option C

Local Manufacturing

5–9 months
  • Manufacturing transfer to Dolphin (Class A–D)
  • MD-5 / MD-9 CDSCO licensing
  • Duty-free COGS optimisation
  • Lowest cost, strongest pricing advantage

Local manufacturing — Dolphin LifeScience

Gujarat's prominent medical device cluster, with free-zone duty-free import and export pathways — up to 50% manufacturing cost reduction.

Certifications & Registrations
US FDA Registered · ISO 13485 Certified · CE Marked · CDSCO A–D Licensed
Cleanrooms
9 manufacturing + 2 testing, 7,760 sq ft ISO 7
Sterilisation
2 ETO machines, ISO 11135 validated, 588 CF
Packaging
14 sealing machines — Tyvek, paper pouch, blister
Products made
Coronary stents, PTCA balloons, catheters, valves

Distribution & sales

A vast network of commercial channel partners, experienced sales professionals, and deep KOL relationships across every major geography.

Indian Distribution Network
Mumbai Delhi NCR Bengaluru Chennai Hyderabad Pune Kolkata Cochin
Key Markets
India
The fastest-growing major economy in the world
South Africa
Africa's most industrialised economy, and gateway to Sub-Saharan Africa
Saudi Arabia
The Middle East's largest economy, investing $65B+ in healthcare under Vision 2030
UAE
The Middle East's healthcare & logistics hub, bridging global markets
Therapy coverage
Cardiac & Interventional Cardiology Robotic & MIS Ortho, Spine & Neuro Diagnostics & Vascular
Our Clients & Partners

Global MedTech innovators who trust Indical

Across CRO, regulatory, manufacturing, and distribution services, Indical partners with some of the world's most innovative medical technology companies.

Foldax

Cardiac Surgery · Heart Valves
Regulatory · India Entity · Clinical Trial · Commercial

Avvio Medical

Microbubble Kidney Stone Treatment
Regulatory · India Entity

Lupin Dental

Robotic Dental Surgery
Regulatory · Clinical Trial · Commercial Launch

CMR Surgical

General Surgery · Robotic
First-in-Human · Regulatory · India & Middle East entities · Commercial

SmartSurgN

4K ICG Visualization System
Regulatory · Clinical Evaluation · Commercial Launch · Distribution

270 Surgical

Surroundscope Visualization System
Regulatory · Distribution
Success Story

CMR Surgical · Versius Robotic Surgical System

1st
First-in-Human robotic surgery in India
Indian Entity
Legal entity established by Indical
AMEA
Full commercial launch across the region
Challenge

CMR Surgical (Cambridge, UK) needed a trusted India partner to navigate CDSCO approvals, establish a local entity, conduct India's first-in-human robotic surgery evaluation, and activate a commercial pathway across the AMEA region — within an aggressive timeline.

Indical's Role

Served as Authorised Indian Representative, managed all CDSCO regulatory submissions, established CMR Surgical's Indian legal entity, coordinated the first-in-human evaluation across top surgical centres, and activated the AMEA commercial distribution channel.

Our Leadership Team

Global MedTech expertise, deep India knowledge

LK

Laxmikant Khanolkar

Managing Director
SR

Sanjay Rane

Logistics & Operations Lead
SB

Shruti Bhat

RA/QA & Manufacturing Lead
MJ

Dr. Manisha Jadhav

Clinical Research Lead
AP

Abhishek S. Padmanabhan

Finance Lead
The Partnership Journey

From first conversation to commercial success

Week 1

Discovery Call

We understand your product, therapy area, and commercial goals for India.

Weeks 2–3

Strategy & Pathway

Tailored India entry strategy: regulatory, clinical plan, distribution model.

Week 4

NDA & Agreement

NDA and service agreement executed. Scope, timelines and terms agreed.

Months 2–4

Regulatory Submission

Indical files the application to CDSCO.

As applicable

Clinical Execution

If required, Indical's CRO runs India clinical evaluations or registry studies.

Months 10–18

Commercial Launch

Product approved. Distribution activated. First sales and ongoing support.

Let's Build Your India Story

India's single-window MedTech partner, since 2012

India HQ

Indical MedSurg Pvt Ltd

A/4, Ground Floor, Vile Parle Colony CHSL
Sahakar Road, Vile Parle (East)
Mumbai – 400057, India

T: +91 9623243509
E: manisha@indicalmed.com
Dr. Manisha Jadhav
Clinical Research Lead
Major Holding Company

Partisan Healthcare Advisory

16 Technology, Suite #165
Irvine, CA 92618
USA

T: +1-949-892-7812
E: brad@partisanmed.com
Brad Sharp
CEO, Partisan Healthcare Advisory