RLD and Bioequivalence Asia
Expert Generic Drug Support
Reference Listed Drug (RLD) Sourcing and Bioequivalence Review
Navigate complex bioequivalence requirements for successful generic drug registration across Asia. Our expert team provides comprehensive RLD sourcing, BE study analysis, and biowaiver strategies to accelerate your generic drug approvals.
Product Categories We Support
Comprehensive RLD & BE Solutions Across All Drug Categories
Pharmaceutical Products:
• Pharmaceuticals
• Originator & Innovator Drugs
• Generic Drugs
• Biologics, Biosimilars
• Orphan Drugs
RLD and Bioequivalence Services
Reference Listed Drug (RLD) Sourcing and Bioequivalence Review
• Bioequivalence (BE) Study gap analysis assessment and review
• BE Study Drug sourcing with legitimate receipts
• RLD temperature monitored transport
• RLD check for validity of BE study for successful generic drug application
• RLD check for validity of physicochemical and clinical study of Biosimilar drug registration
Our Experience
Proven Success in Generic Drug Market Access
First-to-Market Generic Expertise
PECAN.Solutions has helped Generic Drug manufacturers, especially branded or first Generics, with successful market access by reviewing for BE study waivers or biowavers, where applicable.
Critical Success Factors for Generic Registration
Having the necessary and compliant Bioequivalent study report and Comparative Dissolution Profile studies in place is crucial to:
• Acceptance and successful registration outcome of your generic drug
• Meeting regulatory requirements for market approval
• Achieving competitive market positioning
Strategic BE Study Planning
It is essential that generic drug applications are submitted with:
• Clear Bioequivalent study strategies or biowavers
• Proper Reference Listed Drug selection and validation
• Appropriate study design to achieve successful outcomes
The use of acceptable Reference Listed Drug or the lack of such will make or break your registration outcome.
Proven Track Record
We have many positive registration outcomes of first-to-market branded generics with consultation and guidance provided to our clients to:
• Review and remediate the lack or insufficiency of BE or CDP studies
• Advise and support in appeals to health authorities where possible
• Achieve BE study approvals or waivers with acceptance to overseas BE studies, where appropriate
How We Can Help
Complete RLD & Bioequivalence Solutions for Your Generic Programs
BE Study Strategy & Assessment
• Assess appropriateness of BE studies conducted overseas
• Evaluate eligibility of BE study centres for acceptability of BE study reports
• Develop BE study strategy for regulatory acceptance
• Review BE study strategy to obtain BE study waivers and biowavers, reducing costs for clients
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RLD Sourcing & Validation
• Review RLD source to avoid repeating BE studies or rejection of registration dossiers
• Purchase Reference Listed Drug from country of origin or more economical sources
• Obtain BE study drugs with original receipts and temperature monitored transit to study labs or clinical trial sites
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Regulatory Strategy & Appeals
• Appeal to Health Authorities on acceptance of BE studies
• Provide sound BE strategy backed by science and assessment reports
• Navigate complex regulatory requirements for successful approvals
Why Choose PECAN.Solutions for RLD & Bioequivalence
Your Competitive Advantage in Generic Drug Development
First-to-Market Expertise
Proven track record helping branded generics achieve successful first-to-market positioning through strategic BE study planning and execution.
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Scientific Excellence
Expert review and assessment of BE studies, biowaiver strategies, and regulatory compliance to ensure optimal registration outcomes.
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Global RLD Sourcing
Access to Reference Listed Drugs from optimal sources with proper documentation and temperature-controlled transport to ensure study validity.​
Cost Optimization
Strategic biowaiver and BE study waiver approaches that significantly reduce development costs while maintaining regulatory compliance.
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Risk Mitigation
Comprehensive RLD validation and BE strategy review to prevent costly registration failures and study repetitions.
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Regulatory Advocacy
Expert support in health authority appeals and negotiations for BE study acceptance, including overseas studies where appropriate.
Our Case Studies Resolving Bioequivalent Challenges
Proven Success in Complex BE Scenarios
• First to Market branded Generic under 8-year data protection
• Strength of branded generic not registered by innovator
• Choice of Reference Listed Drug where innovator had withdrawn licence
• Unsatisfactory Bioequivalence study results from RLD
• Bioequivalent study centre data integrity issues
• Feasibility study on BE study on Generic with new route of administration
Ready to Accelerate Your Generic Drug Success?
Let's Optimize Your RLD & Bioequivalence Strategy
Don't let bioequivalence challenges delay your generic drug approvals. Our expert team, with proven success in first-to-market generics, is ready to navigate complex RLD sourcing, BE study requirements, and regulatory strategies to accelerate your Asian market entry.
What You'll Get:
• Comprehensive BE study gap analysis and strategic planning
• Expert RLD sourcing with proper documentation and transport
• Biowaiver strategies to reduce development costs and timelines
• Regulatory appeal support for challenging approval scenarios
Contact us today to discuss how our RLD and bioequivalence expertise can ensure your generic drug success across Asian markets.