Regulatory Compliance

At Interquim, we operate with a robust quality system focused on regulatory compliance, ensuring the reliable manufacturing of Active Pharmaceutical Ingredients (APIs) for regulated markets.

We operate under Good Manufacturing Practices (GMP), aligned with ICH Q7, NOM-164, and applicable international standards, ensuring traceability, process consistency, and quality control at every stage.

Inspections and audits

Our GMP compliance is supported by inspections from health authorities and regular audits by clients as part of supplier qualification and evaluation processes. Interquim has been inspected by numerous international authorities, including COFEPRIS, FDA, PMDA, MFDS, and ANVISA.

Regulatory support and documentation

To support the registration and supply of APIs within the GMP scope, we provide regulatory support and documentation for regulated markets, including, when applicable, Drug Master Files (DMFs) and documentation prepared in eCTD format. For exports to the European Union, the Written Confirmation issued by COFEPRIS is available, as indicated in our GMP certificate.

Regulatory audits and assessments

As part of our commitment to quality and regulatory compliance, Interquim maintains high manufacturing standards and has undergone audits and evaluations by health authorities and domestic and international customers.

These include audits of:

COFEPRIS: Federal Commission for the Protection against Sanitary Risk.
FDA: United States Food and Drug Administration.
MFDS: Ministry of Food and Drug Safety.
PMDA: Pharmaceuticals and Medical Devices Agency.
ANVISA: National Health Surveillance Agency.
National and international customer audits: conducted on an ongoing basis as part of supplier evaluation and qualification processes.