AI agents: Pharma
What each Pharma agent does, an example, the monthly effect and payback.
- Regulatory Change (Variations) Control
Manages changes to registrations (change of substance supplier, composition, manufacturing) and their approval with the regulator.
Payback 4-5 months - Agent for Labeling and INCI Control
Checks labels and INCI lists for correct ingredient order, mandatory inscriptions, language, and format according to target market requirements.
Payback 8-13 months - Multi-Market Registration Compliance
Maintains a matrix of dossier requirements by country and highlights what needs to be completed for each market.
Payback 4-6 months - Advertising Claims Verification
Verifies marketing claims about drugs for compliance with the approved dossier and legislation.
Payback 4-5 months - Assembly of Registration Dossier
Assembles and verifies the completeness of the registration dossier (quality, safety, efficacy) according to regulatory requirements.
Payback 4-6 months - PIF Generation Agent
Collects and maintains the Product Information File (PIF): composition, specifications, safety data, manufacturing data, and cosmetic product safety report in accordance with requirements.
Payback 6-10 months - CMR and Allergen Control Agent
Detects CMR substances and declarable fragrance allergens in ingredients, and generates a list for labeling according to current thresholds.
Payback 3-5 months - CPNP Notification Agent
Prepares data for product notification in CPNP (category, framework formulation, CMR, nano-ingredients) and tracks notification status across the portfolio.
Payback 6-11 months - Ingredient Restriction Verification Agent
Cross-references the formula's composition with regulatory lists (prohibited, restricted, permitted preservatives and colorants by annexes) for the target market.
Payback 7-12 months - Adverse Reaction Database and Traceability
Maintains a structured database of adverse reaction reports linked to drugs and batches.
Payback 4-5 months