Global regulatory & compliance advisors

Regulatory clearance for exporters and manufacturers.

We resolve USFDA import alerts and detention without physical examination (DWPE), close compliance gaps against 21 CFR, and keep shipments from being refused at the border — across food, pharma, devices, cosmetics, supplements and chemicals.

Where we are asked in

A shipment was detained
Product is on DWPE or a red list and entries are being refused.
An inspection raised observations
GMP, HACCP or quality-system findings that need a corrective plan.
A new market is opening
Labeling, records and SOPs have to hold up before the first entry.

Overview

Where to start

Five pages cover the firm and the work: who we are, what we do, the notes we have written by situation, the alerts and code sections the work is built on, and the industries we serve.

About us

Who we are, how we read a compliance failure, and the firms we are asked in to help.

Services

From an active detention through to the analytics that keep it from returning.

Guidance

Longer notes on the situations we are called into most often.

Regulatory framework

The alerts and code sections our work is built on.

Sectors

From raw commodities at origin to finished products on a US shelf.

Contact

Your global partner in compliance excellence.

Send the alert number, the product and the entry documents. We come back with a read on the violation and what a removal petition would require.

management@paramountwa.com
Email
management@paramountwa.com
Telephone
+1 929-214-1308
Address
B52, C10, Villa Los Naranjos, Res. El Sauce, Tegucigalpa, Honduras