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. No retainer lock-in. Scale up or down as priorities shift.

I — Regulatory & Product Strategy

License to operate and compete

For

Pharma · Agrochemical · Biotech · Medical Devices · Diagnostics · Cannabis · Specialty Chemicals

What We Do

  • Regulatory pathway design (India, EU, US, OECD)
  • Product registration & dossier strategy (CTD / ICH / OECD)
  • Study gap analysis vs. target approvals
  • Pre-submission scientific positioning
  • Sponsor-side CRO & lab oversight
  • Regulatory intelligence & horizon scanning

What You Get

  • Predictable approvals
  • Reduced regulatory risk
  • Faster market entry
  • Defensible regulatory narratives

II — Regulatory & Quality Systems

Compliance that survives reality

For

Laboratories · CROs · Pharma Manufacturing · Diagnostics · Any Regulated Facility

What We Do

  • GLP & ISO 17025 gap assessments
  • Mock inspections & audit readiness
  • OECD study lifecycle mapping
  • Data integrity & ALCOA+ remediation
  • CAPA, QMS & ERP-enabled quality systems
  • NABL accreditation support (ISO 17025)

What You Get

  • Inspection-resilient systems
  • Fewer repeat observations
  • Compliance that survives attrition
  • Lean, sustainable quality infrastructure

III — R&D Consultation

Ability to scale responsibly

For

Laboratories · CROs · Scale-ups · Greenfield Facilities

What We Do

  • Lab operating model design
  • Capacity & utilisation planning
  • Build vs buy vs outsource decisions
  • Lean process optimisation
  • ERP & digital workflow implementation
  • Service portfolio & pricing architecture

What You Get

  • Predictable delivery
  • Margin clarity
  • Scalable operations
  • Data-driven capacity decisions

IV — Training, Talent & Capability Advisory

People are your regulatory infrastructure

For

Labs · CROs · Scale-ups · Global Firms Entering India

What We Do

  • Scientific & regulatory role architecture
  • Interviewing & technical evaluation panels
  • Leadership capability assessment (QA, TFM, SDs)
  • Academic → industry transition support
  • Competency frameworks for regulated roles
  • Succession planning for critical GLP positions

What You Get

  • Reduced people risk
  • Leadership continuity
  • Faster, safer scaling
  • Inspection-resilient teams

V — Visibility & Marketing

Credibility at scale

For

Any Life-Science Organisation Building Market Presence

What We Do

  • Scientific & regulatory brand positioning
  • Founder & leadership authority building
  • Websites, pitch decks & LinkedIn narratives
  • Whitepapers & technical explainers
  • Conference narratives & booth science
  • Search visibility for regulated offerings

What You Get

  • Faster sponsor trust
  • Shorter sales cycles
  • Visibility aligned with truth
  • Investor-ready narratives

VI — Knowledge, AI & Learning Systems

Institutional intelligence

For

Laboratories · CROs · Pharma · Any Organisation with High Knowledge Turnover

What We Do

  • AI-enabled knowledge management
  • eLearning (GLP, QA, OECD, study lifecycle)
  • LMS integration & learning analytics
  • Internal knowledge retention & transfer
  • Regulatory intelligence dashboards
  • Competency-based assessment design

What You Get

  • Continuous readiness
  • Lower training cost
  • Knowledge that survives attrition
  • Measurable competency outcomes

Not sure which domains apply to you?

30-minute discovery call. We’ll map your situation to the right domains — no obligation.