APIChemX/Compliance
Compliance

Every trade checked before it is quoted.

Every request is screened before a supplier is contacted. Every supplier is checked before a quote is sent. Where a licence is needed, we confirm it is in place before the order moves.

Screening

Four checks before a quote.

01

Buyer

Company registration, licences where relevant, and an end-use statement for sensitive materials.

02

Product

Name, CAS and structure confirmed, with the grade, specification and regulatory requirements of your market.

03

Supplier

GMP certificate, inspection history and DMF or CEP status checked on regulator databases.

04

Transaction

Sanctions screening of every party, route and bank, and a review of anything unusual in price or routing.

Document review

The pack we read before you see a price.

We request what your market and QA team require, and flag anything missing, expired or inconsistent.

Certificate of analysis

Batch-specific, against the agreed specification and pharmacopoeia.

Safety data sheet

Current revision, GHS-compliant, with transport classification.

GMP certificate

Issued by a regulator, in date, covering the site and the product.

DMF or CEP access

Letter of access or CEP copy for your filing.

Written confirmation

For APIs imported into the EU from non-EU countries.

TSE/BSE statement

For materials of animal origin or made with them.

ICH Q3C and Q3D

Residual solvents and elemental impurities statements.

Nitrosamine risk

Assessment for APIs where nitrosamine formation is plausible.

FAQ

Common questions.

What checks happen before a quote?
Four: the buyer (registration, licences, end use), the product (identity, specification and market requirements), the supplier (GMP, inspections, DMF or CEP) and the transaction (sanctions screening of every party, route and bank).
Which documents does APIChemX review?
Certificate of analysis, safety data sheet, GMP certificate, DMF or CEP access, written confirmation for EU imports, TSE/BSE statement, ICH Q3C and Q3D statements and a nitrosamine risk assessment where relevant.
Start here

Have a compliance question first?

Ask before you send the requirement. If we cannot handle a trade, we will say so at the start.

WhatsApp, the fastest route to the desk+230 5505 7361
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