REGULATORY SUPPORT

Your Seamless Path to Market

Altruist has a dedicated and highly experienced Regulatory Affairs team to support your drug filing and registration efforts for domestic and international markets. With a proven track record of successful filings with global regulatory authorities, you can rely on us to help you navigate the current and emerging requirements for biologics and advanced therapies.

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Our Track Record

We have supported and provided documentation for over 70 IND projects and 18 BLAs/NDAs/MAAs since we first established our regulatory affairs team.

We support clients through every stage of regulatory interaction, from pre-IND submission to market authorization applications.

Our Service Offerings

CMC Advisory Service

CMC Support

We provide CMC project planning and guidance to achieve the fastest regulatory pathway while minimizing risks and maintaining quality.

Expert partner to navigate China’s evolving regulatory landscape
Gap and risk assessments for single or multi-regional filings including the U.S., E.U., China, Australia, Asean, and other major markets
Proven track record with FDA, EMA, PMDA, and NMPA submissions

Regulatory Submission Support

Pathway to Approval

Our regulatory offerings are customized to support you at each critical milestone.

Extensive expertise in CMC dossier preparation, updates and amendments, including IND, IMPD, DSUR, NDA, BLA, and PAC submissions
Author CMC sections for IND, IMPD, BLA, MAA and NDA
Comprehensive review of regulatory documents to improve application success rate
Health authority meeting support and customized preparation
Post-approval change management support

Registration & Inspection Support

Global Readiness

We provide technical assistance for information requests from health authorities and support on-site facility inspections and other compliance activities.

Regulatory Intelligence Monitoring

Policy & Guidance Monitoring

We are constantly monitoring the evolving regulatory landscape in China and other international markets as well as its impact on key processes and timelines.

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Discuss Your Project

Our experts understand the evolving regulatory landscape and its impact on key processes and timelines. Learn how we can support you whether you have a standard filing or a fast-track application.

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