AI Expert in Pharma & Biotech for Belgium
Get precise answers and professional documents in Pharma & Biotech with DOCTOR PHARMA, your specialized AI consultant.
DOCTOR PHARMA
Pharma & Biotech
Expertise in Pharma & Biotech
Specialist skills tailored to the Belgian regulatory context.
MA & registration
Marketing authorization (national, MRP, DCP, EMA centralized), CTD/eCTD dossier, variations, renewals, generics (bioequivalence)
FAMHP regulation
Federal Agency for Medicines and Health Products, GMP inspections, manufacturing/distribution authorizations, import/export, narcotics/psychotropics
Pharmacovigilance
QPPV, adverse reaction reporting, PSMF, PSUR/PBRER, safety signals, risk management plans (RMP)
Clinical trials
EU Regulation 536/2014, CTIS, Ethics Committee, informed consent, GCP, SUSAR, clinical trial insurance
Medical devices
MDR 2017/745, IVDR 2017/746, CE marking, classification (I/IIa/IIb/III), notified body, EUDAMED, post-market surveillance
NIHDI reimbursement
Drug Reimbursement Committee (CRM), chapter IV, forms, maximum price, article 81 conventions, managed entry agreements
Pharmacy & dispensing
Pharmacy opening/transfer (moratorium), GPP (Good Pharmaceutical Practices), magistral/officinal preparations, hospital pharmacy, duty
Biotech & biological medicines
Biosimilars, advanced therapies (ATMP), orphan drugs, biological production, cold chain, GDP
Pharmaceutical advertising
Medicine advertising (Book V ELC + RD 07/04/1995), medical visits, samples, MDEON (mandatory visa), transparency of advantages
Medical cannabis & controlled substances
Legal framework for medical cannabis in Belgium, special FAMHP authorizations, narcotics (1961 convention), psychotropics
Cosmetics & food supplements
EC Regulation 1223/2009 cosmetics, CPNP notification, food supplements (RD 03/03/1992), novel food, health claims
Pharma intellectual property
Pharma patents, SPC (Supplementary Protection Certificate), data exclusivity (8+2+1), Bolar exemption, generics litigation
Patient rights & reimbursements
BIM/OMNIO status, maximum billing (MAF), third-party payment, NIHDI reimbursement categories (A/B/C/Cs), co-payment, global medical record, Belgian patient rights
Use cases for your business
MA, clinical trials, pharmacovigilance, NIHDI, biotech — DOCTOR PHARMA drives regulatory compliance for your pharma company.
Complete MA dossier
Prepare a marketing authorization dossier (national or European)
Launch a clinical trial
Procedure and obligations to conduct a clinical trial in Belgium
Pharmacovigilance system
Set up a compliant pharmacovigilance system
NIHDI reimbursement
Build a reimbursement application for the CRM
CE marking medical device
Obtain CE marking under MDR 2017/745
GMP manufacturing
Obtain and maintain GMP-compliant manufacturing authorization
Use cases for individuals
Medicines, side effects, generics, reimbursement — DOCTOR PHARMA guides you through the Belgian pharmaceutical world.
Medicine side effects
Understand and report an adverse drug reaction
Generic vs brand medicine
Understand the difference and bioequivalence of generics
Medicine reimbursement
Check if a medicine is reimbursed by the health fund/NIHDI
Safe self-medication
Rules for buying over-the-counter medicines in Belgium
Medical cannabis
Legal framework for medical cannabis in Belgium
Duty pharmacy
Find the duty pharmacy and understand the on-call system
Discover the impact
A complete platform
More than a chatbot: professional tools to manage your business.
25 specialized AI agents
Each sector has its dedicated expert, trained in Belgian law and practices.
Smart chat
Contextual conversations with web search and document analysis.
Document vault
Secure storage with automatic AI analysis and deadline alerts.
AI meetings
Multi-agent meetings with automatic synthesis and PDF export.
AI document editor
Draft, correct and translate professional documents.
Regulatory monitoring
Automatic tracking of legal changes impacting your sector.
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