Quality
cGMP, GDP and ICH Q7/Q9/Q10 across manufacturing and distribution.
Operating across many jurisdictions means answering to many authorities at once. Eknox engineers to the most demanding common denominator — so one quality and integrity system carries across every market.
Compliance is not the ceiling. It is the floor.
Governments, manufacturers, regulators and capital trust Eknox because our 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.
cGMP, GDP and ICH Q7/Q9/Q10 across manufacturing 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 U.S. production and partner manufacturers to cGMP (21 CFR Parts 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, accurate, and complete, consistent, enduring and available — making our submissions defensible before any authority.
We apply DSCSA-aligned traceability and serialization principles, validated handling, and documented chain-of-custody from manufacturer to point of dispensing.
Post-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 compliance framework applies to your products and markets.