Services Offered
Dossier preparation
Clinical trial application
CTD/e-CTD
Scientific Reports/Technical writing
Strategic advice
DMFs
Manufacturing licenses, inspections
Expert reports and statements
Management of submission
Staff replacement
Maintenance (variations, renewal)
Compliance and Quality Assurance/audit
Due Diligence and data evaluation
Regulatory Intelligence
IND/NDA
Project management
Training services
Readability Testing
Regulatory Agencies
EMEA
MHRA
Other EC nationals
Central and Eastern Europe
Export Markets
FDA
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Specialities
Generics
Patient leaflets/SmPC and labeling
Biotechnology
Drug Safety
Biologicals
Enviromental Risk assessment
Notification of new substances/industrial chemicals
Research exemptions
Parallel imports
Orphan Drugs
Topical products
Borderline products
Hearings/Oral explanations
Expert witness services
Preclinical data evaluation and strategy
Law and ethics advice
Formulation development
Animal health
OTC/Legal status change
Medical Devices
Herbals
Chemistry, Manufacturing & Controls
Other non-regulatory services
Clinical trials
Data management
Qualified Person
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