SIG Consulting

FDA Regulatory Services

Facility Registration

Foreign food and dietary supplement facility registration, biennial renewal, and US Agent designation

FCE & SID Registration

FDA registration of low-acid canned food (LACF) and acidified food processes and facilities

cGMP

Gap assessment against GMP requirements with written findings and prioritized remediation plan

HACCP

HACCP plan development and validation for human food, seafood, and juice imports

Preventive Controls

Food safety plan review, implementation, and PCQI-level guidance for preventive controls programs

Traceability (FSMA 204)

Early adoption strategy and compliance support for FSMA Section 204 food traceability requirements

Program Development

Turnkey FSVP design, hazard analysis, supplier risk categorization, and documentation for human food and animal food imports

Program Review

Gap assessment of existing FSVP programs against current FDA enforcement expectations

FSVP Templates

Ready-to-use FSVP program documentation, hazard analysis templates, and recordkeeping forms

FSVP Importer

We serve as the listed FSVP Importer and manage all compliance obligations on your behalf

Supplier Evaluation & Verification Activities

Supplier evaluation & verification activity selection, scheduling, records maintenance, and ongoing program management

Inspection Support

On-site or remote support during live FDA FSVP inspections including document review and investigator liaison

Hold Resolution

Rapid-response support for FDA-detained shipments — admissibility documentation, entry strategy, and release coordination

Import Alert Removal

Strategic petition to remove products from FDA's Import Alert red list, including evidence package and FDA division liaison

Green List Addition

Expedited placement on the Import Alert green list to bypass automatic detention

Registration & Listing

Foreign drug establishment registration and drug listing submission and maintenance

Import Admissibility

Drug import admissibility assessment and refused entry response strategy for finished drugs and APIs

Section 804 SIP

Regulatory support for FDA-authorized Section 804 drug importation programs from Canada

Registration & Listing

Foreign device establishment registration and device listing in FDA's FURLS system

Regulatory Pathway

Pathway determination — Q-sub, 510(k), De Novo, PMA, or 513(g) Request for Classification

Registration & Listing

MoCRA facility registration and product listing for foreign cosmetic manufacturers, including biennial renewal

Responsible Person

Responsible person designation, legal obligations assessment, and compliance program setup

Safety Substantiation

Cosmetic safety data compilation and safety information file (SIF) preparation to meet MoCRA adequacy standards

Registration

Foreign biologics facility registration and BLA import compliance guidance

Import Admissibility

Admissibility assessment for vaccines, blood products, plasma derivatives, and biosimilars

Registration & Listing

Registration and product listing for imported tobacco and nicotine products via FDA's Center for Tobacco Products

Standards Compliance

Tobacco product standard compliance review: nicotine levels, flavors, modified risk claims, and packaging

Foods & Dietary Supplements

Foreign Supplier Verification (FSVP)

Imports

Drugs

Medical Devices

Biologics

Tobacco Products

Cosmetics

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Labeling

FDA-compliant label review including nutrition facts, allergen declarations, and panel format requirements

Claims

Structure/function, health, and nutrient content claim review for dietary supplement and food imports

Prior Notice

Prior Notice preparation, filing, and correction support for all imported food and dietary supplement shipments

Mock Inspections

Simulated FDA facility inspection conducted by a former FDA investigator to identify readiness gaps

483 & Warning Letters

Comprehensive, defensible FDA Form 483 and Warning Letter responses with full remediation planning

Recalls

Voluntary recall and market withdrawal strategy, classification, documentation, and FDA communications

Mock FSVP Inspections

Realistic FSVP inspection simulations by a former FDA investigator with 150+ FSVP inspections conducted

483 & Warning Letters

Comprehensive, defensible FDA Form 483 and Warning Letter responses with full remediation planning

Produce Safety

Produce Safety Rule compliance support and gap assessments for covered produce importers

Dietary Supplement FSVP

FSVP programs specifically tailored to dietary ingredient and finished dietary supplement importers

VQIP

VQIP eligibility assessment, application preparation, quality assurance program development, and renewal support

US Agent Services

Designated US Agent and official FDA point of contact for all foreign facility types across all commodity categories

Refused Entry

Reconditioning, relabeling, and destruction coordination for FDA-refused import entries

Labeling

Drug product label review covering active ingredients, indications, warnings, and directions for use

Claims

Drug vs. supplement intended use risk assessment for imported food, supplement, and drug-marketed products

UDI

UDI labeling compliance review and GUDID database submission and management

Labeling & Claims

Device label review including UDI requirements, instructions for use, and IFU adequacy. Device marketing claim review for intended use accuracy, truthfulness, and freedom from drug/device misclassification

Ingredient Compliance

Fragrance, allergen, colorant, and FDA-prohibited ingredient compliance review, including batch certification

Adverse Event Reporting

SAER system setup, reporting protocol development, and submission support for importers and responsible persons

Labeling

Cosmetic label review: ingredient declarations, responsible person, country-of-origin, and format compliance

IVD/IND Imports

Investigational or in-vitro diagnostic biological product import compliance support

Lot Release

Batch record review and CBER/CDER coordination for imported biologics

Labeling

Tobacco product label review for FDA regulatory compliance

Our FDA Compliance Process

01

Discovery & Audit

We begin with a comprehensive review of your current regulatory landscape, identifying gaps and potential risks across all FDA-regulated categories.

02

Strategy & Design

Our team develops a tailored compliance roadmap, focusing on document control, labeling accuracy, and ensuring alignment with evolving FDA guidance.

03

Implementation & Support

We provide ongoing support to ensure your operations remain fully compliant, offering expert advice and continuous monitoring to prevent violations.