Our Services
Regulatory Affairs
Regulatory Strategy and Consultation
US ANDA and Canadian ANDS Submission
Importer and Drug Establishment Licencing
Artworks and Product Labels
eCTD Publishing
US Agent and Regulatory Contact
Drug Master File (DMF) Submission
CMC Support
CMC Gap Assessment
Writing and Reviewing CMC Sections
QOS and CPID Writing
Genotoxic Impurity Assessment and QSAR
CMC Product Development Support
Quality Target Product Profile Development
Post Approval and Product Lifecycle Management
Quality Compliance
Supplier Qualification and Management, Including Auditing and Monitoring
Standard Operating Procedures (SOPs) and Validation Protocols
Quality Risk Management and Failure Mode and Effects Analysis (FMEA)
Process Characterization and Product Quality Monitoring