Altruist has a dedicated and highly experienced Regulatory Affairs team to support your drug filing and registration efforts. We have supported regulatory submissions for multiple NDA/BLA applications as well as over 30 IND applications.
As an expert partner to navigate the ever-changing regulatory landscape, we provide both regulatory and technical services throughout your product’s entire lifecycle, while minimizing risks and maintaining quality.
As an expert partner to navigate the ever-changing regulatory landscape, we provide both regulatory and technical services throughout your product’s entire lifecycle, while minimizing risks and maintaining quality.
Consultation service
Gap and risk assessment of research content, strategic and regulatory advice, and CMC project planning and guidance.
Dossier Filing
Preparation of CMC dossiers, including CN-IND, US-IND, IMPD, DSUR, IND Amendments, NDA, BLA, and PAC submissions, and a comprehensive review of regulatory documents to improve application success rate.
Health Authority Meetings
Regulatory meeting support and customized preparation services.
Registration & Inspection Support
Dedicated teams to provide technical assistance for information requests from health authorities, and support on-site facility inspections and other compliance activities.
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