Regulatory Consulting Services
EAS Consulting Group, our regulatory consulting arm under the Certified Group banner, specializes in comprehensive FDA and USDA regulatory consulting for several regulated industries, including food and beverage, dietary supplement, over-the-counter (OTC) drug, pharmaceutical, medical device, cosmetic, and animal and pet products. Our expertise helps you meet the requirements of the U.S. FDA, USDA, and other regulatory bodies so you can rest assured of your compliance.
Industries We Serve
We serve the smallest startups to the largest manufacturers across multiple regulated industries. Our technical staff and team of close to 200 independent consultants, including former FDA personnel, respond to inquiries quickly to help ensure label and claim compliance, verify regulatory compliance, audit your environmental monitoring program, and much more.
Food & Beverage
Dietary Supplements
Over-the-Counter (OTC) and Rx Drugs
Medical Devices
Cosmetics
Animal and pet products
Regulatory Consulting Services for Food and Beverage Companies
Our food safety consulting services are designed to help you comply with regulations under the FDA and USDA.
FSMA compliance
Hazard Analysis and Risk-Based Preventive Controls (HARPC)
Good Manufacturing Practices (GMP) assessments
Development of food safety plans
Food Submissions
We assist with all aspects of food submissions to ensure your products meet regulatory requirements for market entry and continued compliance.
- New dietary ingredient notifications (NDINs)
- Generally Recognized As Safe (GRAS) determinations
- Food additive petitions
USDA Consulting Services
We provide expert guidance on USDA regulations to help your business comply with requirements for meat, poultry, and egg products.
- USDA label approvals
- Compliance with USDA regulations for meat and poultry products
- Organic certification assistance
Food Labeling and Claims Support
Our food labeling specialists help you navigate the complexities of food labeling regulations, ensuring your labels and claims are accurate and compliant.
- Label reviews and approvals
- Nutritional labeling and ingredient statements
- Health and nutrient content claims verification
- Structure/function claims support
- Claims substantiation
- Compliance with FDA and USDA labeling requirements
Additional Services for Food & Beverage
- Due diligence assessments
- 483 and Warning Letter remediation
- Recall assistance
- U.S. Agent and import assistance
Regulatory Consulting for the OTC Drug Industry
EAS Consulting Group offers comprehensive regulatory consulting services for the Over-the-Counter (OTC) drug industry, ensuring compliance with FDA regulations and market success.
OTC Drug Submissions and Monographs
We assist with OTC drug submissions, developing and reviewing monographs, and preparing filings for FDA approval.
- Rx to OTC Switch, Direct to OTC NDA
- Cosmetic-to-OTC Crossover
- Citizen Petitions
- OTC Time and Extent Applications (TEA)
Labeling and Claims Substantiation
We offer expert guidance on drug labeling, claims verification, and compliance with FDA requirements.
- Structured Product Labeling (SPL)
- Label reviews and formatting
GMP, GLP, and GCP Support
Our consultants provide audits and assessments to ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
Additional Services for the OTC Industry
- Contract partner audits
- eCTD submissions
- Expert witness services
- 483 and Warning Letter remediation
- Recall assistance
- U.S. Agent and import assistance
Regulatory Consulting Services for the Dietary Supplements Industry
EAS Consulting Group offers expert consulting services for the dietary supplements industry, ensuring compliance with FDA and FTC regulations and helping you navigate the complexities of product formulation, labeling, and marketing. Our services include formulation support, product development support, ingredient and finished product specifications, label and labeling review, claims review and substantiation, SOP support, GMP audits, FDA claim notification, New Dietary Ingredient (NDI) notification, and more.
Dietary Supplement Labeling and Claims
We ensure your product labels and claims meet FDA regulations, focusing on accuracy and regulatory adherence.
- Label review
- Nutritional and ingredient statements
- Health and structure/function claims support
- Claims substantiation
New Dietary Ingredient (NDI) Notifications & GRAS
We assist with preparing and submitting NDI notifications for new ingredients to the FDA, as well as GRAS determinations.
- NDI dossier preparation
- Safety assessments
- Regulatory strategy development
- GRAS determination and submissions
Good Manufacturing Practice (GMP) Audits
Our team conducts thorough GMP audits to ensure your manufacturing processes comply with FDA requirements.
- Mock inspections
- Quality systems assessments
- Compliance audits
- Regulatory gap assessments
Additional Services
- 483 and Warning Letter remediation
- Recall assistance
- Adverse events support
- U.S. Agent and import assistance
Regulatory Consulting Services for the Cosmetics Industry
EAS Consulting Group offers expert consulting services to the cosmetics industry, ensuring compliance with the Federal Food, Drug, and Cosmetic Act; MoCRA; and the Fair Packaging and Labeling Act. Our services include help with formulation development, evaluating formulation safety, safety substantiation, label and labeling review, claims review, adverse events support, facility registration, product listing, color additive petitions, support with INCI and CIR, and GMP audits. We also offer 483 and Warning Letter remediation, recall assistance, and import assistance.
Cosmetic Labeling and Claims
We review product labels and claims, ensuring compliance with FDA and FTC regulations and preventing misbranding. Our experts help craft compliant claims to keep your product regulated as a cosmetic.
Good Manufacturing Practice (GMP) Audits
Our team conducts thorough GMP/Quality Systems audits of your facilities to assess and enhance compliance.
Submission of Color Additive Petitions
We assist with preparing and submitting color additive petitions to the FDA, ensuring ingredient safety and compliance.
Cosmetic Registrations Under MoCRA
We assist with facility and product registrations under MoCRA, ensuring your organization is compliant with the regulations.
Contact Us for Regulatory and Scientific Consulting for Your Industry
Tell us what you need in the form below and our team will respond, typically within one business day.