Quality
cGMP, GDP and ICH Q7/Q9/Q10 across production and distribution.
Operating across many jurisdictions means answering to many authorities at once. Eknox builds to the most demanding common standard — so one system of quality and integrity carries across every market.
Compliance is the floor, not the achievement.
Governments, developers, regulators and capital trust Eknox because the standard does not move from market to market. We build every engagement to satisfy the strictest applicable framework, document it to an auditable standard, and stand behind it long after the work is done.
cGMP, GDP and ICH Q7/Q9/Q10 across production and distribution.
FCPA, UK Bribery Act, ABAC and OFAC sanctions screening.
ALCOA+ principles governing every record we keep.
DSCSA-aligned traceability and serialization.
We hold our own production and partner producers to cGMP (21 CFR 210/211) and ICH Q7, with systems governed by ICH Q10 and risk managed under ICH Q9. CAPA closes the loop on any deviation.
Every counterparty and government engagement is screened against FCPA, UK Bribery Act and OFAC requirements. Due diligence is documented and refreshed, and our ABAC program governs all interactions with public officials.
Records adhere to ALCOA+ — attributable, legible, contemporaneous, original and accurate, and complete, consistent, enduring and available — which is what makes our submissions defensible before any authority.
We apply DSCSA-aligned traceability and serialization principles, validated handling, and documented chain of custody from production to the point of dispensing.
After authorization, we maintain Good Pharmacovigilance Practices, manage variations and renewals, and report safety signals to relevant authorities for the life of each product.
Ask how our framework applies to your products and markets.