PARAMOUNT 

WORLDWIDE ADVISORS

Global Regulatory & Compliance Advisors for Exporters and Manufacturers Worldwide.

About us

We help businesses across food, agriculture, pharma, cosmetics, dietary supplements, medical devices, chemicals, and related sectors navigate USFDA and international regulatory requirements, resolve import alerts, and prevent shipment refusals

Company Overview

Paramount Worldwide Advisors is a global consultancy specializing in:

  • USFDA import alerts, detention without physical examination (DWPE), and watch‑list prevention for multiple industries.

  • Compliance with food and drug regulations, device quality systems, cosmetic standards, and dietary supplement GMPs.

  • Integration of international standards (ISO, HACCP, CGMP) with local production and export practices.

Regulatory Framework

Import Alert & DWPE Resolution (All Industries):

  • Raw agricultural products (all commodities) under alerts like 99‑05 for pesticides.

  • Processed foods, seafood, dietary supplements, cosmetics, drugs, animal feed, and medical devices under various import alerts (e.g., alerts for salmonella, viral contamination, illegal colors, GMP failures, unapproved devices, misbranding).

USFDA Regulatory & Documentation Consulting

  • Food, beverages, and dietary supplements (Title 21 CFR Parts 101, 111, 114, 117, 123, 54‑series alerts).

  • Drugs and APIs (CGMP, new drug approvals, misbranding, inspection refusals).

  • Medical devices and quality systems (21 CFR Part 820, PMA/IDE and 510(k) issues).

  • Cosmetics (color additive violations, microbiological contamination, adulteration/misbranding).

Services

Import Alert & DWPE Resolution (All Industries):

  • Review of the specific alert and underlying violations.

  • Root‑cause and risk analysis across farming, manufacturing, packaging, labeling, and distribution.

  • Development of corrective and preventive action plans.

  • Preparation of petitions and supporting documentation to request removal from DWPE/red lists and minimize the risk of repeat issues.

USFDA Regulatory & Documentation Consulting

  • Regulatory gap analyses and compliance roadmaps.

  • SOP, record, and labeling reviews across product categories.

  • Assistance in electronic systems and records alignment (Part 11 considerations).

Strategic Compliance & Risk Analytics

  • Trend analysis of testing failures, pesticide residue distributions, microbiological results, and inspection observations across product lines.

  • Risk scoring and prioritization to focus resources on high‑impact corrective actions.

  • Dashboards and KPI frameworks to track compliance performance over time across multiple facilities and geographies.

Industries & Sectors

Agriculture & Raw Commodities: Fresh fruits and vegetables, grains, nuts, herbs and spices—all raw products potentially subject to pesticide and contamination alerts (e.g., 99‑05 for raw agricultural commodities).

Processed Foods & Beverages: Packaged foods, juices, canned products, frozen items, confectionery, oils.

Seafood & Animal Products: Fish, fishery products, meat, dairy, eggs and related items subject to HACCP and contamination alerts.

Pharmaceuticals & APIs: Finished drug products, active ingredients, generics, OTC products.

Dietary Supplements & Nutraceuticals: Vitamins, herbal products, sports nutrition, functional foods.

Medical Devices & Diagnostics: Devices requiring PMA/IDE or 510(k), quality system compliance (QSR).

Cosmetics & Personal Care: Skin care, hair care, color cosmetics, fragrances, hygiene products.

Chemicals & Industrial Products: Industrial chemicals, intermediates, ingredients used in food, pharma, and cosmetics.

Environmental, Water & Gas Testing: Laboratories and facilities needing validated testing for environmental matrices, water, and gases like COâ‚‚.

You can reach us at:

  • Email: haredcastro@gmail.com

  • Telephone: +(504) 9825- 9208

  • Address: B52, C10, Villa Los Naranjos, Res. El Sauce, Tegucigalpa, Honduras.

Your global partner in compliance excellence.