Alcance del servicio: Respalda cambios previos a la aprobación en productos NDA pioneros, presentaciones ANDA y cambios posteriores a la aprobación mediante estudios de bioequivalencia.
Escala de lote: Opera 84 camas de estudio y ha completado más de 200 estudios de BE utilizando más de 120 métodos validados.
Certificación regulatoria: Aprobado por la NPRA de Malasia y el DCGI de la India (acreditado por CDSCO); realiza estudios bajo ICH-GCP y SOP alineados con la FDA.

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Descripción adicional:

Bioequivalence studies support certain pre-approval changes to pioneer NDA products, ANDA submissions, and post-approval changes. This facility operates 84 study beds, has completed more than 200 BE studies using over 120 validated methods, and is approved by Malaysia's NPRA and India's DCGI (CDSCO-accredited). Its experienced team of doctors, nurses, and pharmacists runs studies in both healthy volunteers (including female-specific studies) and patients under ICH-GCP and FDA-aligned SOPs, backed by an independent quality assurance team conducting online audits; supplied from China, India, North Korea, and Malaysia.