Boutique Science-Business Consultancy · India
Building Compliant, Profitable, and Credible Life-Science Organisations
Modular advisory that delivers deep, execution-ready expertise across regulatory science, quality systems, R&D operations, talent, strategic communication, and AI-enabled learning. Engage only the capabilities you need, when you need them.
One system. Six domains. Modular engagement.
From regulatory pathway design to AI-powered learning systems — the rigour of the lab applied to the boardroom.
What LaborWissen Is
A boutique science-business consultancy.
We advise businesses, laboratories, CROs, sponsors, investors, and academic spin-offs on the four pillars that make life-science organisations succeed.
01 — Compliant System Design
Quality, regulatory, and operational frameworks that stand up to audits and scale with your ambitions.
02 — Profitable Operations
Cost control, service design, pricing architecture, and commercial strategy that protects margins.
03 — Credible Communication
Scientific, regulatory, and investor-ready narratives that earn trust before meetings happen.
04 — Visible Growth
Branding, content strategy, and digital presence built for regulated life-science markets.
The LaborWissen Service Architecture
Six domains. One system. Modular engagement.
Each domain operates independently or in concert. Pick what you need, when you need it.
I — Regulatory & Product Strategy
Regulatory pathway design, dossier strategy, study gap analysis, pre-submission positioning. India, EU, US, OECD jurisdictions.
II — Regulatory & Quality Systems
GLP & ISO 17025 gap assessments, mock inspections, ALCOA+ remediation, CAPA & QMS implementation.
III — R&D Consultation
Lab operating model design, capacity planning, lean process optimisation, ERP & digital workflows.
IV — Training, Talent & Capability
Role architecture, technical evaluation panels, leadership assessment, competency frameworks.
V — Visibility & Marketing
Scientific brand positioning, authority building, whitepapers, conference narratives, search visibility.
VI — Knowledge, AI & Learning
AI-enabled knowledge management, eLearning, LMS integration, regulatory intelligence dashboards.
Who We Serve
Built for organisations whose currency is knowledge.
Pharma & Biotech
Regulatory pathway design, dossier strategy, and pre-submission positioning for companies navigating CDSCO, FDA, and EMA approvals.
Laboratories & CROs
GLP and ISO 17025 compliance, lab operating model design, capacity planning, and audit readiness.
Medical Devices & Diagnostics
Product classification, registration strategy, and quality system design for Indian and global markets.
Sponsors & Investors
Technical and regulatory due diligence, risk assessment, and portfolio evaluation.
Academic Spin-offs
Translational strategy, IP commercialisation, and academic-to-industry transition support.
Global Firms Entering India
Market entry advisory, regulatory landscape mapping, talent architecture, and partner evaluation.
How We Work
From first conversation to measurable outcomes.
1 — Discovery Call
A 30-minute conversation to understand your organisation, challenges, and regulatory context. No cost, no obligation.
2 — Diagnostic & Scoping
We map your situation and propose a tailored scope of work within 48 hours. Clear deliverables. Fixed timeline.
3 — Modular Engagement
Activate only the domains you need. Fixed-fee or retainer. Scale up or down. No lock-in.
4 — Execution & Transfer
Execution-ready outputs and knowledge transfer so your team sustains momentum independently.
Insights
Thinking from the intersection of science, regulation, and business.
Regulatory intelligence, quality systems thinking, and operational strategy for life-science leaders.
Ready to build something compliant, profitable, and credible?
30-minute discovery call. No pitch deck. Just sharp questions and clear next steps.