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PHI Corporation
PHI Corporation
Regulatory Affairs Outsourcing for
Pharmaceutical & Biotechnology
We help Pharmaceutical and Biotechnology companies shorten the time of securing their marketing authorizations. We also provide GxP requirements consulting and assistance that is essential in the application and maintenance of their licenses that is a pre-requisite for a company before they can apply for marketing authorization to the health authorities.
SERVICES
We deliver timely and outstanding outcomes by understanding the history, trends, and updates from our industry partners and the Regulatory Authorities in a target region.
REGULATORY CONSULTING & STRATEGY
- Regulatory strategies on product development stage
- Regulatory strategies on entering the target market
- Regulatory strategies on active substance and finished product sourcing
- Regulatory strategies on documentation and archiving
- Regulatory strategies on dossier writing, translation, and format
- Regulatory strategies on dossier submission
- Regulatory strategies on artwork label design and compliance
- Regulatory strategies in compliance to Regulatory authority queries
- Regulatory strategies on post-approval compliance
- Regulatory strategies on lifecycle monitoring
- Regulatory strategies on pharmacovigilance
REGULATORY OPERATIONS OUTSOURCING
We offer tailored regulatory affairs operations end-to-end programs for start-ups, small-, medium- and large-size companies.
We provide life sciences companies tailored, high-efficient and up-to-date regulatory affairs solutions to comply with the strict and ever-changing standards of regulatory authorities.
TAILORED PROGRAM FOR START-UPS
- Regulatory Intelligence
★ Regulatory requirements overview, including health authorities and customs requirements.
★ Dossier requirements review
★ History and pattern review of approvals, denials, recalls, post-marketing
compliances
★ Regulatory updates reporting
- Regulatory Strategies
- Regulatory Representation
- Target Market Avenue
- Regulatory Documentation
- Regulatory Lifecycle Monitoring
- Regulatory Labelling and Artwork compliance
- Regulatory Technology Implementation and Validation
SERVICES
END-TO-END REGULATORY AFFAIRS OUTSOURCING
We take importance to the vision of each client and make it the foundation of our strategy while prioritizing to shorten the approval of licenses and marketing authorizations.
SERVICES
REGULATORY SUBMISSION MANAGEMENT
★ Submission Planning
★ Content Authoring
★ Component Coordination and Assembly
★ Publishing
★ Internal Review
★ Dispatch and Archive
01
REGULATORY INTELLIGENCE MANAGEMENT
★ Registration Management
★ Labelling Management
★ Health Authority Correspondence
★ Commitment Tracking
★ Regulatory Intelligence
★ Authority Updates
02
DOSSIER CONVERSION AND TRANSLATION
★ ASEAN Common Technical Dossier (ACTD)
★ Electronic Common Technical Document (e-CTD)
03
SERVICES
REGULATORY DOCUMENTATION
- Regulatory Applications/Filings
- Supporting Documents Consolidation
- Product Development Documentation
- Manufacturing Documents and Control Data
- Reports to and from Health Authorities
- Clinical Studies Documentation
- Drug Master File
- Quality Management System Alignment
- Document Control and Archiving
- Lifecycle Monitoring
- Amendments and Variations
- Post-marketing Compliances