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RLD and Bioequivalence

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Image by Headway
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Speak with Us

  • Pharmaceuticals

  • Originator & Innovator Drugs

  • Generic Drugs

  • Biologics, Biosimilars 

  • Orphan Drugs

RLD and Bioequivalence

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

Image by Scott Graham
Image by Headway
Image by Campaign Creators

Our Experience

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.

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Having the necessary and compliant Bioequivalent study report and Comparative Dissolution Profile studies in place is crucial to the acceptance and successful registration outcome of your generic drug.

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It is essential that generic drug applications are submitted with clear Bioequivalent study strategies or biowavers in order to achieve such successful outcome. The use of acceptable Reference Listed Drug or the lack of such will make or break your registration outcome.

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We have many positive registration outcome 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, and are able to advise or support in appeals to the health authority where possible for BE study approvals or waivers, with acceptance to overseas BE studies, where appropriate.

How we can help

  • Assess for appropriateness of BE studies conducted overseas, eligibility of BE study centres for acceptability of BE study report, BE study strategy for regulatory acceptance

  • Review of RLD source to avoid repeating BE study or rejection of registration dossier

  • Review of BE study strategy to obtain BE study waivers and biowavers thus reducing cost for clients

  • Purchase of Reference Listed Drug from country of origin or more economical source

  • Obtaining BE study drug with original receipts and temperature monitored transit to study lab or clinical trial site

  • Appeal to Health Authority on acceptance of BE study with sound BE strategy backed by science and assessment reports

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Our case studies resolving Bioequivalent challenges

  • First to Market branded Generic under 8-year data protection

  • Strength of branded generic not registered by innovator

  • Strength of branded generic not registered by innovator

  • Choice of Reference Listed Drug where innovator had withdrawn licence

  • 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

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