MEDICAL UMBRELLA
Scientific, clinical, medical communication, evidence, and commercial-medical functions
A. Medical Affairs & Scientific Strategy
Medical affairs strategy development
KOL mapping and engagement planning
Scientific communication strategy
Medical launch excellence
Medical information systems & query management
MSL training & capability building
Real-world evidence (RWE) program design
Evidence generation planning
Medical monitoring advisory support
B. Clinical Development & Drug Development Support
Pre-clinical strategy guidance
Clinical development plans & protocol design
Endpoint selection & comparator strategy
Risk-based monitoring strategy
Trial feasibility and site selection
Biostatistics & data management advisory
C. Medical Communication & Content Excellence
Medical writing (clinical, regulatory-linked, safety, HEOR)
Scientific content development
Promotional and non-promotional content
MLR review support (medical review component)
Publication planning & manuscript support
Digital scientific assets (MOA videos, e-learning, scientific platforms)
D. Market Access, Pricing & HEOR (Medical-Scientific Portion)
HEOR modelling (cost-effectiveness, budget impact)
Value story development & clinical narrative
AMCP/GVD value dossiers (scientific portion)
Clinical components for payer communication
E. Digital & AI (Medical-Focused Solutions)
AI-driven literature screening
AI-assisted medical writing
Digital clinical trial tools (ePRO, remote monitoring)
Data analytics dashboards for medical insights
REGULATORY UMBRELLA
Regulations, compliance audits, approvals, quality systems
A. Regulatory Affairs & Strategy
Regulatory pathway assessment (FDA, EMA, CDSCO, MHRA, PMDA)
Dossier preparation: IND, NDA, BLA, ANDA, CTA, variations
Labelling strategy, safety language, prescribing information
Regulatory intelligence (global updates monitoring)
Safety communication & REMS support
Regulatory strategy for product lifecycle
B. Pharmacovigilance
Periodic safety report support (DSUR, PBRER writing – regulatory component)
Safety governance structures
PV system audits & compliance checks
Signal detection framework advisory
LEGAL UMBRELLA
IP, compliance, ethics, contracts, and legal-risk domains
A. Intellectual Property (IPR) & Patent Strategy
Patent search & prior art evaluation
Freedom-to-operate (FTO) analysis
Patent drafting assistance
Lifecycle management (patent term strategies)
Brand protection and infringement risk assessment
B. Compliance, Ethics & Legal Governance
Ethics & compliance framework development
Anti-bribery, anti-corruption advisory
Data integrity compliance (legal risk component)
Contractual risk assessment
Policy development & SOP legal validation
C. Corporate & Strategic Legal Advisory
M&A due diligence (legal risk side)
Business contracts, licensing & partnership evaluations
IP clauses assessment in collaborations
Legal aspects of technology transfer agreements
D. Digital & AI (Legal/Safety Governance)
Data privacy compliance (GDPR, HIPAA equivalents)
Legal oversight of AI-based systems
Contractual risk in digital/AI vendor selection



