MEDWISDOM is a pharmaceutical consultant. We offer a wide range of services in the areas of pharmaceutical development, Regulatory affairs, Patent, Clinical, Non clinical, Manufacturing, Facility audit.
REGULATORY AFFAIRS:
 Dossiers (eCTD /CTD /NeeS /EAC /ASEAN/Country specific format)
 Conversion of Non-CTD to CTD or CTD to eCTD or NTA to eCTD
 Product lifecycle Management (Renewal and variation)
 Drug master file (DMF) and CEP
 MEDICAL DEVICES
 EXPERT REPORT (Quality/nonclinical/clinical)
 Company registration
INTELLECTUAL PROPERTY
 Evaluation of Product / process patents
 Development strategies as per non infringing technologies
 Patent drafting and submission
PACKAGING DEVELOPMENT
 Development of packaging components
 Proposing the packaging material specifications
 Development of packaging change parts
ANALYTICAL DEVELOPMENT
 Development of new analytical methods for Assay, RS, Dissolution etc.
 Validation of analytical methods
 Transfer of analytical methods from lab to QC
FORMULATION DEVELOPMENT
 Development of New pharmaceutical products – tablets / capsules / powders /
injections / eye drops / Injections / Creams / Ointments
 Resolving any bio‐equivalence challenges
 Reformulation of existing products
 Simplification of complex manufacturing processes of existing products
 Stability improvement in existing products
 Cost reduction of existing products
 Technology Transfer from lab scale to exhibit batch / commercial scale
 Suggestion of new equipment
 Designing of R&D Laboratories etc.
TECHNOLOGY TRANSFER
 Ready technology (Formulation as well as API) for execution
TRAINING
 GMP/ISO Training
 Technical training
 Regulatory training
AUDIT:
 Quality Management system audit
 GxP Audit
PHARMACOVIGILANCE:
 Pharmacovigilance System Establishment
 Development of Risk Management Plan (RMP), Periodic Safety Update Reports (PSUR)/PBRER/PADER
 Safety Data Exchange Agreements
 Safety Database
 Technical team trainings
 ICSRs: Processing & Reporting
 QPPV Services
 Audit & Inspection support
 Signal detection & management
 Global & local literature surveillance
 xEVMPD/IDMP Support
 other Pharmacovigilance Consulting Support
OTHER SERVICE:
 Clinical and non-clinical support
 Export and import
 Local Agent (India)

MEDWISDOM is a pharmaceutical consultant. We offer a wide range of services in the areas of pharmaceutical development, Regulatory affairs, Patent, Clinical, Non clinical, Manufacturing, Facility audit.
REGULATORY AFFAIRS:
 Dossiers (eCTD /CTD /NeeS /EAC /ASEAN/Country specific format)
 Conversion of Non-CTD to CTD or CTD to eCTD or NTA to eCTD
 Product lifecycle Management (Renewal and variation)
 Drug master file (DMF) and CEP
 MEDICAL DEVICES
 EXPERT REPORT (Quality/nonclinical/clinical)
 Company registration
INTELLECTUAL PROPERTY
 Evaluation of Product / process patents
 Development strategies as per non infringing technologies
 Patent drafting and submission
PACKAGING DEVELOPMENT
 Development of packaging components
 Proposing the packaging material specifications
 Development of packaging change parts
ANALYTICAL DEVELOPMENT
 Development of new analytical methods for Assay, RS, Dissolution etc.
 Validation of analytical methods
 Transfer of analytical methods from lab to QC
FORMULATION DEVELOPMENT
 Development of New pharmaceutical products – tablets / capsules / powders /
injections / eye drops / Injections / Creams / Ointments
 Resolving any bio‐equivalence challenges
 Reformulation of existing products
 Simplification of complex manufacturing processes of existing products
 Stability improvement in existing products
 Cost reduction of existing products
 Technology Transfer from lab scale to exhibit batch / commercial scale
 Suggestion of new equipment
 Designing of R&D Laboratories etc.
TECHNOLOGY TRANSFER
 Ready technology (Formulation as well as API) for execution
TRAINING
 GMP/ISO Training
 Technical training
 Regulatory training
AUDIT:
 Quality Management system audit
 GxP Audit
PHARMACOVIGILANCE:
 Pharmacovigilance System Establishment
 Development of Risk Management Plan (RMP), Periodic Safety Update Reports (PSUR)/PBRER/PADER
 Safety Data Exchange Agreements
 Safety Database
 Technical team trainings
 ICSRs: Processing & Reporting
 QPPV Services
 Audit & Inspection support
 Signal detection & management
 Global & local literature surveillance
 xEVMPD/IDMP Support
 other Pharmacovigilance Consulting Support
OTHER SERVICE:
 Clinical and non-clinical support
 Export and import
 Local Agent (India)