What we do.

Our work runs from an active detention through to the analytics that keep it from returning. Whatever the starting point, it ends the same way: in documentation a regulator can read and a plan the facility can follow.

Import alert & DWPE resolution

Review of the specific alert and the underlying violations.
Root-cause and risk analysis across farming, manufacturing, packaging, labeling and distribution.
Corrective and preventive action plans (CAPA).
Petitions and supporting documentation to request removal from DWPE and red lists.

USFDA regulatory & documentation consulting

Regulatory gap analyses and compliance roadmaps.
SOP, record and labeling reviews across product categories.
Alignment of electronic systems and records with Part 11 considerations.
Integration of ISO, HACCP and CGMP with local production and export practice.

Strategic compliance & risk analytics

Trend analysis of testing failures, pesticide residue distributions, microbiological results and inspection observations.
Risk scoring to prioritize high-impact corrective actions.
Dashboards and KPI frameworks across multiple facilities and geographies.

Who signs and who files

Across all three, we prepare and your firm files. We draft the petition, build the corrective action file and coordinate the laboratory work; the submission to FDA and the correspondence that follows are made by your firm or its United States counsel.