PHI Corporation Logo

PHI Corporation

PHI Corporation Logo

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