Eas Consulting Group, LLC

Multi-day seminars and short courses delivered virtually on topics such as dietary supplement GMPs, CSV/CSA and AI/ML validation, OTC GMPs and labeling.

Global leader in testing and regulatory solutions for FDA and USDA regulated industries, assisting clients in developing regulatory strategies, implementing quality assurance programs, filing regulatory submissions, and ensuring compliance with FDA regulations.

Comprehensive virtual audit and regulatory consulting services provided by EAS Consulting Group, utilizing video technology, document reviews, and staff interviews to assess compliance with FDA, USDA, EPA, and international regulations.

Virtual consulting options for food regulatory and compliance challenges.

EAS Consulting Group serves as US Agent for importers of FDA regulated products into the United States, acting as an intermediary between FDA and the foreign firm.

Services providing US Agent representation and import compliance assistance for international and domestic food firms.

Assistance with FDA submissions including Premarket Notifications (510k), De Novo Applications, IDEs, PMAs, and Pre-Submission Dossiers.

EAS Consulting Group provides regulatory consulting services to lead companies through GRAS, Food Additive Petitions (FAP), Food Contact Notifications (FCN), New Dietary Ingredient Notifications (NDIN), and Color Additive Petitions (CAP) submission processes.

Regulatory consulting services for food, GRAS, NDIs, FCNs, and temporary marketing permit submissions to the FDA.

Consulting and compliance services specializing in FDA regulatory matters, helping foreign food manufacturers and US food importers navigate FSMA import regulations, FSVP importer setup, supplier assessments, and regulatory training.

Mock-FDA inspections and inspection support for foreign facilities to determine deficiencies and assist with corrective actions.

Consulting services to help firms respond to local, state, FDA, USDA, or EPA scrutiny or regulatory actions including Form 483s and Warning Letters.

Professional consulting services assisting firms with the preparation of FDA 483 responses and FDA inspection responses following Form 483 observations or Warning Letters, including corrective action plans and compliance remediation strategies.

Assistance and consulting related to USDA regulatory requirements for food production and processing.

Consulting and regulatory support regarding USDA FSIS, AMS, and APHIS requirements for food products.

Assistance with obtaining USDA APHIS Animal and Plant Health Permits.

Consulting services assisting food companies with ensuring labels meet FDA regulatory requirements, assessing formatting elements, nutrition facts panels, ingredient lists, and various claims.

An intensive training program to help firms prepare for increased FDA enforcement and understand new industry rules on good manufacturing practices (GMPs).

A seminar providing necessary preparation for dietary supplement labels to comply with FDA requirements, addressing mandatory elements and allowable claims.

An intensive virtual training program covering FDA 21 CFR 111 cGMP requirements, compliance, quality control, and inspection readiness for dietary supplements.

Design and review of labels and package inserts to ensure compliance with FDA regulations for health claims and structure function claims.

An 8-hour GMP Refresher training detailing an overview of expectations and compliance requirements to help employees stay on top of critical issues pertaining to GMPs in the dietary supplement industry.

Consulting services to assist FDA-regulated firms with electronic records and electronic signatures compliance under 21 CFR Part 11, including SOP reviews, validation plans, and IQ/OQ/PQ studies.

Regulatory assistance and consulting services for FDA food manufacturers to help achieve and maintain compliance with the FSMA 204 Food Traceability Rule.

Consulting and filing support for Abbreviated New Animal Drug Applications (ANADAs).

Consulting and preparation support for Abbreviated New Drug Applications (ANDAs).

Assistance service for foreign food facilities to register with the FDA in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, including biennial renewals.

Registration and listing services and US Agent services providing communication conduit between FDA and foreign facilities.

Regulatory assistance and independent expert witness services for law firms and in-house counsel handling FDA regulatory compliance disputes, mediation, and litigation.

Expert witness support for regulatory, legal, and compliance matters related to food production and safety.

A virtual training seminar covering FDA's Foreign Supplier Verification Program (FSVP) under the Food Safety Modernization Act (FSMA) regulation, taught by an FSPCA FSVP Lead Instructor.

Consulting and compliance services to help U.S. importers and foreign manufacturers navigate FDA Foreign Supplier Verification Program (FSVP) requirements.

Comprehensive regulatory and compliance consulting services provided by former FDA, USDA, and state agency officials for the pharmaceutical, medical device, food, dietary supplement, tobacco, and cosmetic industries.

Comprehensive consulting, training, and auditing services to assist with FDA product submissions, regulatory filing plans, and maintaining facility registrations and product listings.

Comprehensive consulting, training, and auditing services specializing in FDA regulatory matters, Good Manufacturing Practices (GMPs), and quality systems for the cannabis, hemp, and CBD industry.

Expert guidance across the biologics and Biosimilars lifecycle from development to manufacturing, compliance, and post-market obligations.

Mock FDA inspection of foreign facilities to determine deficiencies, evaluate compliance, and develop corrective action plans.

Reduced-rate food safety and regulatory consulting services designed to help food companies demonstrate compliance with U.S. FDA, USDA, and global certification standards.

Thorough and complete GMP audits of onsite or contractor manufacturing, packaging, distribution, and laboratory facilities including mock-FDA inspections.

Independent compliance assessments and mock FDA-inspection services with detailed analysis and gap identification.

Consulting and assessment services specializing in FDA regulatory matters, identifying regulatory risks, and compliance gaps for FDA and USDA regulated companies.

Cost-effective consulting and audit support from former FDA and USDA experts to help human and animal food companies strengthen food safety systems and stay compliant with federal regulations.

Strategic consulting service providing solutions to companies confronting product development and labeling issues by considering marketing objectives and the regulatory, compliance, and enforcement environment.

Assistance with all pharmaceutical submissions and amendments to FDA and Health Canada including NDA, ANDA, DMF, IND, NADA, and ANADA.

A five-part series on OTC GMPs and Labeling Compliance covering what you need to know to manufacture and market your products in accordance with FDA requirements, including inspection enforcement, labeling requirements, private label distributors, registrations and listings, and designing an effective Adverse Events Reporting program.

Assistance with drug submissions including IND, DMF, ANDA, and amendments.

Consulting and compilation assistance for New Drug Applications (NDAs).

Assistance with medical device applications and correspondence including 510(k), 513(g), PMA, and IDEs.

Facility audits, GAP analysis, and recommendations for improvements covering GMP, GLP, and GCP regulations.

Assistance with the preparation and submission of 510(k) pre-market clearance applications for medical devices.

Development and review of OTC drug monographs, filing submissions, and responses to Agency initiatives.

Review of tobacco manufacturing procedures and quality systems, including SOP preparation and maintenance standards for tar and nicotine.

Webinars offering regulatory overviews of hot topics that enable greater industry understanding with compliance expectations.

Comprehensive consulting service for Generally Recognized as Safe (GRAS) determinations, Food Contact Notifications (FCNs), and Food Additive Petitions, guiding companies through study design, expert oversight, and FDA submission dossiers.

Establishment registrations for FDA regulated products.

Consulting services to ensure compliance with 21 CFR Part 820 Quality System Requirements and ISO 13485 QSR.

Assistance with the preparation and maintenance of Drug Master Files (DMF).

Customizable in-house training delivered in-person or remotely at your facility, specific to business needs and delivery requirements.

Support for NDI premarket notifications and GRAS submissions through safety data oversight and preparation.

An intensive virtual training program instructing participants on FDA requirements for Drug Good Manufacturing Practices (GMP) under 21 CFR 210 and 211, helping firms prepare for FDA enforcement and inspections.

Regulatory consulting services to help organizations evaluate potential impacts, prepare for future compliance obligations, and navigate FDA tobacco registration and product listing requirements.

Support for FDA submissions, applications, annual registrations, Premarket Tobacco Applications (PMTA), Modified Risk Tobacco Applications (MRTP), and Substantial Equivalence Submissions (SE).

Preparation and filing assistance for New Dietary Ingredient (NDI) notifications.

Consulting services for De Novo classification requests for novel medical devices.

Regulatory training services conducted in-house or publicly for food safety, compliance, and quality systems.

Produce Safety regulatory consulting services for domestic operations and produce exported into the U.S., helping organizations minimize regulatory risk through assessments, evaluations, and compliance consulting.

Consulting support for preparing and filing food and color additive petitions with the FDA.

A one-day intensive seminar on Good Manufacturing Practice (GMP) compliance in the dietary supplement laboratory.

Review of medical device labels, packaging, and claim appropriateness to ensure compliance with FDA requirements.

Technical sessions delivered by EAS representatives at industry tradeshows and conferences around the world.

Consulting support for Investigational Device or Drug Exemption applications.

Consulting assistance for Generally Recognized As Safe (GRAS) determinations and notifications.

Assistance with Tobacco Premarket Tobacco Product Applications (PMTA) submissions.

Consulting assistance for New Animal Drug Applications (NADA).

Assistance with Substantial Equivalence reports and applications for tobacco products.

Assistance with Investigational New Drug (IND) applications and device equivalents.

Assistance with preparing and submitting New Infant Formula Notifications to the FDA.

Assistance with Food Contact Substance Notifications (FCN) for substances intended for use in food-contact materials.

Expert review of formatting, nutrition information, and claims for pharmaceutical and OTC drug labels.

Assistance with National Drug Code listings.

Consulting addressing supply chain management, storage, specifications, and testing for retailers and own label distributors.

Assistance with FDA fast-track designation and application processes.

Review of tobacco product labels for required FDA information, ingredient disclosure, and advertising restrictions compliance.

Consulting for Modified Risk Tobacco Applications (MRTPs).

Expert compliance status assessments, third-party audits, and regulatory risk determinations conducted by EAS for mergers, acquisitions, and investments.

Consulting and advisory services for structure/function claim notifications.

Consulting and filing services for acidified and low acid canned foods.

Consulting and compliance services for the Food Safety Modernization Act (FSMA), helping organizations stay ahead of safety issues and maintain regulatory compliance.

Customized and prepared in-house training programs covering various aspects of cosmetics regulation and industry standards to fit your company's specific needs.

Assistance with reporting adverse events and developing protocols for remediation.

Assistance with the preparation of Quality Agreements specific to organizational contractual relationships under cGMP guidelines.

Consulting for Temporary Marketing Permits for food products deviating from established standards.

Virtual training course utilizing the FSPCA standardized curriculum recognized by the FDA to meet the requirement for a Preventive Controls Qualified Individual (PCQI).

Servicios de consultoría en español para la Verificación de Proveedores Extranjeros del FDA.

Consulting and guidance services to assist food firms in managing and executing product recalls.

A complimentary webinar discussing the FDA rule establishing a uniform 12-digit National Drug Code format.

Assistance with Medical Device Reporting (MDR) to the FDA and developing protocols for the remediation of adverse events.

Basic Seafood HACCP training course.

Establishment registration and process filing for acidified and low-acid canned foods.

A type size guide offered by EAS Consulting Group for labeling requirements.

Assistance with the registration of importers and DUNS numbers.

Specialized consulting services for cross-border food shipments and regulatory adherence.