Through active involvement in manufacturing and direct interaction with laboratories and manufacturers, GNH USA can undertake internationally acceptable stability studies, BA/BE studies and eCTD dossier preparation.
Stability & BA/BE
Internationally acceptable study quality
Stability studies for Zone 4 countries
ICH-compliant stability protocols for high-temperature/high-humidity zones.
BA / BE studies
Bioavailability and bioequivalence studies for pharmaceuticals and biologicals.
Bioavailability
BA data for a formulation provides an estimate of the relative fraction of an orally administered dose absorbed into the systemic circulation. BA studies also yield pharmacokinetic information on distribution, elimination, the effects of nutrients, and dose proportionality.
Bioequivalence
BE and product-quality BA focus on the release of a drug substance from a drug product and subsequent absorption into the systemic circulation.
CTD dossier preparation
Dossiers that meet the most demanding standards
eCTD format
Electronic Common Technical Document compatible with FDA, EMA and equivalent regulators.
Regulated markets
EU and US standards — quality, safety, efficacy and module 3 strength.
Semi-regulated & unregulated
Dossiers tuned to local registration requirements outside the major regulators.
Manufacturer-grade insight
Our own manufacturing experience informs the dossiers we prepare.
FAQ
Frequently asked questions
What is an eCTD dossier?
The electronic Common Technical Document (eCTD) is the standard electronic format for submitting regulatory dossiers. GNH USA prepares eCTD dossiers compatible with the FDA, EMA and equivalent regulators.
Which markets do you prepare dossiers for?
We prepare dossiers for regulated markets such as the US and EU, as well as semi-regulated and unregulated markets, tuned to each market's local registration requirements.
What is the difference between bioavailability and bioequivalence studies?
Bioavailability (BA) studies estimate the fraction of an administered dose that reaches systemic circulation, while bioequivalence (BE) studies compare a product's drug release and absorption against a reference. GNH USA undertakes both for pharmaceuticals and biologicals.
Do you offer stability studies for hot and humid climates?
Yes. We run ICH-compliant stability studies, including Zone IVb protocols for high-temperature and high-humidity countries.
Why choose a partner with manufacturing experience for dossiers?
GNH USA's direct involvement in manufacturing and its laboratory relationships inform the dossiers we prepare, improving the quality and acceptability of submissions.
Related
Other services
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Reference-listed drug and active comparator supply for clinical trials worldwide — direct from manufacturer, with WHO GDP-compliant logistics.
Clinical Trials Supply
End-to-end IMP sourcing, kitting and depot-to-site logistics — GDP-compliant warehousing, manufacturer relationships and a full source-to-site audit trail.
Name Patient Supply
Compliant supply of unlicensed and rare medicines for individual patients. WHO GDP-certified, with verified prescriptions and validated cold-chain shipping.