Originator & Innovator Drugs
Expert Generic Drug Support
Product Categories We Support Comprehensive RLD & BE Solutions Across All Drug Categories Pharmaceutical Products:
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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
First-to-Market Generic Expertise
PECAN.Solutions has helped Generic Drug manufacturers, especially branded
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:
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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:
The use of acceptable Reference Listed Drug or the lack of such will make or break your registration outcome.
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Clear Bioequivalent study strategies or biowavers
Proper Reference Listed Drug selection and validation
Appropriate study design to achieve successful outcomes
Proven Track Record
We have many positive registration outcomes of first-to-market branded generics with consultation and guidance provided to our clients to:
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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
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
RLD Sourcing & Validation
Review RLD source to avoid repeating BE studies
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
PECAN.Solutions covers this as part of the engagement scope.
Obtain BE study drugs with original receipts and
Obtain BE study drugs with original receipts and temperature monitored transit to study labs or clinical trial sites
Regulatory Strategy & Appeals
Proven track record helping branded generics achieve successful first-to-market positioning through strategic BE study planning and execution.
Expert review and assessment of BE studies, biowaiver strategies, and regulatory compliance to ensure optimal registration outcomes.
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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
Global RLD Sourcing
Access to Reference Listed Drugs from optimal sources with proper documentation and temperature-controlled transport to ensure study validity.
Strategic biowaiver and BE study waiver approaches that significantly reduce development costs while maintaining regulatory compliance.
Comprehensive RLD validation and BE strategy review to prevent costly registration failures and study repetitions.
Expert support in health authority appeals and negotiations for BE study acceptance, including overseas studies where appropriate.
Do not 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.
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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
What You'll Get
Contact us today to discuss how our RLD and bioequivalence expertise can ensure your generic drug success across Asian markets.
Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership.
Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations.
We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework.
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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