Who We Serve
Built for organisations whose currency is knowledge.
We work with regulated life-science organisations across stage, size, and sector — from pre-revenue spin-offs to established multinationals entering India.
Industries & Organisations
Deep expertise across the life-science ecosystem.
Pharma & Biotech
Regulatory pathway design, dossier strategy, and pre-submission positioning for companies navigating CDSCO, FDA, and EMA approvals. From generic API manufacturers to novel biologics developers.
Laboratories & CROs
GLP and ISO 17025 compliance, lab operating model design, capacity planning, and audit readiness for contract research organisations.
Medical Devices & Diagnostics
Product classification, registration strategy, and quality system design for medical device and IVD companies targeting Indian and global markets.
Agrochemical & Specialty Chemicals
Regulatory strategy for crop protection products, industrial chemicals, and specialty formulations. OECD GLP study requirements.
Sponsors & Investors
Technical and regulatory due diligence, risk assessment, and portfolio evaluation for investors in the life-sciences space.
Academic Spin-offs
Translational strategy, IP commercialisation frameworks, and academic-to-industry transition support for university-born ventures.
Global Firms Entering India
India market entry advisory, regulatory landscape mapping, talent architecture, and in-country partner evaluation.
Cannabis & Novel Products
Regulatory pathway definition for cannabis-derived products, novel foods, and emerging therapeutic categories.
Government & Public Health
Quality system advisory for government-funded laboratories, public health institutions, and regulatory bodies.
By Organisation Stage
Wherever you are in your journey.
Pre-Revenue — Building Foundations
First-time regulatory interactions, quality system design, team architecture, and go-to-market strategy. Get it right from the start.
Growth — Scaling With Control
Expanding capacity, adding jurisdictions, strengthening compliance systems, and building operational resilience as you grow.
Established — Optimising & Extending
Lean operations, new market entry, leadership development, AI integration, and strategic communication at scale.
Crisis — Rapid Remediation
Post-inspection response, critical observation remediation, data integrity recovery, and regulatory relationship repair.
See yourself here?
30-minute discovery call. We’ll map your situation to the right advisory domains — no obligation.