FDA Consulting Services in Boston, Massachusetts
Services available remotely to all Boston and Massachusetts companies — food manufacturers, biotech and pharmaceutical firms, medical device companies, seafood processors, dietary supplement brands, and cosmetics companies.
- FDA Food Facility Registration — 21 CFR Part 1
- Drug Establishment Registration — 21 CFR Part 207
- Medical Device Establishment Registration — 21 CFR Part 807
- MoCRA Cosmetic Facility Registration & Product Listing
- U.S. Agent Services for Foreign Facilities
- FSVP for Boston-Area Food Importers
- Seafood HACCP — 21 CFR Part 123
- FDA Prior Notice — Port of Boston & Logan Airport
- Food, Drug & Device Label Reviews
- Biennial & Annual Renewal Management
FDA Compliance Services for Every Boston and Massachusetts Industry
| Industry / Company Type | FDA Requirement | CFR Citation | Key Service |
|---|---|---|---|
| Biotech & pharmaceutical companies (Kendall Square, Cambridge, Greater Boston) | Drug Establishment Registration — annual renewal | 21 CFR Part 207 | Drug establishment registration, drug listing, U.S. Agent for foreign API suppliers |
| Medical device manufacturers (Route 128 corridor, Greater Boston) | Device Establishment Registration — annual renewal | 21 CFR Part 807 | Device establishment registration, device listing, U.S. Agent for foreign device suppliers |
| Food manufacturers and processors | Food Facility Registration — biennial renewal | 21 CFR Part 1 Subpart H | Food facility registration, activity code selection, biennial renewal management |
| Seafood processors and distributors (New England seafood industry) | Food Facility Registration + mandatory Seafood HACCP | 21 CFR Part 123 | Seafood HACCP plan development support, registration, FSVP for imported seafood |
| Food importers through Port of Boston and Logan Airport | FSVP + Prior Notice | 21 CFR Part 1 Subpart L & I | FSVP program development, Prior Notice review, supplier registration verification |
| Cosmetics and personal care companies | MoCRA facility registration + product listing — annual renewal | MoCRA (Pub. L. 117-328) | MoCRA facility registration, product listing, U.S. Agent for foreign cosmetics suppliers |
| Dietary supplement manufacturers | Food Facility Registration + dietary supplement cGMPs | 21 CFR Part 111 & Part 1 | Facility registration, Supplement Facts label review, structure/function claim review |
| Foreign companies exporting to Boston-area buyers | FDA registration in applicable category + U.S. Agent | Category-specific CFR | Foreign facility registration, U.S. Agent designation, ongoing compliance management |
Why Boston and Massachusetts Companies Have Complex FDA Needs
Boston and Cambridge’s Kendall Square represent the highest concentration of FDA-regulated biotech and pharmaceutical activity in the world. Massachusetts is also home to a significant medical device cluster along the Route 128 technology corridor, active food and seafood import operations through the Port of Boston and Logan Airport, and a growing dietary supplement and natural products industry.
Biotech & Pharma Hub
Kendall Square in Cambridge and the broader Greater Boston area contain hundreds of biotech and pharmaceutical companies — from clinical-stage startups to global commercial manufacturers. Drug establishment registration under 21 CFR Part 207 and U.S. Agent services for foreign API suppliers are core FDA compliance needs for this cluster.
Medical Device Corridor
Massachusetts’ Route 128 technology corridor hosts significant medical device manufacturing. Medical device establishment registration under 21 CFR Part 807 is required annually (October 1–December 31). Device importers and distributors also require foreign manufacturer registration verification and U.S. Agent coordination for overseas suppliers.
New England Seafood & Food Imports
The Port of Boston (Conley Terminal) and Logan Airport are active food import entry points for New England. Seafood processors in the Boston area face mandatory seafood HACCP requirements under 21 CFR Part 123. Food importers must maintain FSVP programs for each foreign supplier and file Prior Notice for every shipment.
FDA Import Compliance for Boston-Area Food Importers
FSVP — Foreign Supplier Verification
Every U.S. food importer — including companies importing through the Port of Boston and Logan Airport — must maintain a Foreign Supplier Verification Program (FSVP) under 21 CFR Part 1 Subpart L for each foreign food supplier. FSVP requires a written hazard analysis, supplier verification activities, corrective actions, and 2-year recordkeeping. FDA inspects FSVP records and issues Warning Letters for inadequate programs.
Prior Notice — Required Before Every Shipment
FDA Prior Notice under 21 CFR Part 1 Subpart I must be filed before every food shipment arrives at the Port of Boston or Logan Airport: 8 hours for ocean, 4 hours for air, 2 hours for road. Prior Notice must include the correct FDA facility registration number and FDA product code. Errors cause holds at port. FDA Registration Assistance reviews Prior Notice accuracy for Boston-area importers.
Ready to Get FDA-Compliant in Boston, Massachusetts?
FDA Registration Assistance provides complete FDA regulatory consulting for Boston and Massachusetts companies — Food Facility Registration, Drug Establishment Registration, Medical Device Registration, MoCRA Cosmetics, U.S. Agent services, FSVP, label reviews, and seafood HACCP. 1,000+ clients. 135+ countries. 15+ years of FDA regulatory experience. All services available remotely to Boston-area clients.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333.
Frequently Asked Questions — FDA Consulting in Boston, Massachusetts
1. What FDA consulting services are available for Boston, Massachusetts companies?
Complete FDA regulatory consulting for all product categories: Food Facility Registration; Drug Establishment Registration; Medical Device Establishment Registration; MoCRA Cosmetic Facility Registration and Product Listing; FSVP for importers; seafood HACCP compliance under 21 CFR Part 123; food and drug label reviews; and U.S. Agent services. All available remotely to Boston and Massachusetts businesses.
2. Do Boston biotech and pharmaceutical companies need FDA establishment registration?
Yes. Pharmaceutical and biotech companies in Boston and Kendall Square that manufacture drug products must register under 21 CFR Part 207 and renew annually (October 1–December 31). Foreign drug establishments supplying Boston companies must register and designate a U.S. Agent. FDA Registration Assistance provides drug establishment registration and U.S. Agent services.
3. Do Massachusetts medical device companies need FDA establishment registration?
Yes. Medical device manufacturers in Massachusetts must register their establishments under 21 CFR Part 807 annually. Massachusetts’ Route 128 medical device corridor has significant registration needs. Foreign device establishments supplying Massachusetts companies must also register and designate a U.S. Agent.
4. What FDA requirements apply to food companies in Boston and Massachusetts?
Massachusetts food manufacturers and processors must: register under 21 CFR Part 1 Subpart H; comply with FSMA Preventive Controls under 21 CFR Part 117; maintain FSVP if importing food; file Prior Notice for imported shipments; and ensure FDA-compliant labeling under 21 CFR Part 101.
5. Do New England seafood processors need special FDA compliance?
Yes. Seafood processors in the Boston and New England area must comply with mandatory seafood HACCP under 21 CFR Part 123 in addition to food facility registration. Seafood HACCP requires a written HACCP plan, Critical Control Points, critical limits, monitoring procedures, corrective actions, and 2-year recordkeeping. Common New England seafood hazards include C. botulinum in vacuum-packaged fish and Listeria in smoked fish.
6. What FSVP requirements apply to food importers through the Port of Boston?
Food importers at the Port of Boston (Conley Terminal) and Logan Airport must maintain an FSVP under 21 CFR Part 1 Subpart L for each foreign food supplier — written hazard analysis, supplier verification activities, corrective actions, and 2-year recordkeeping.
7. Do Massachusetts cosmetics companies need MoCRA compliance?
Yes. Massachusetts cosmetics companies manufacturing or processing cosmetics must register their facility and list products under MoCRA (Pub. L. 117-328) annually. Foreign cosmetics facilities supplying Massachusetts companies must designate a U.S. Agent. Responsible persons must report serious adverse events within 15 business days.
8. Do dietary supplement companies in Massachusetts need FDA registration?
Yes. Dietary supplement manufacturers in Massachusetts must register their facilities and comply with dietary supplement cGMPs under 21 CFR Part 111. Supplement labels must carry a Supplement Facts panel. Structure/function claims require FDA notification and the required disclaimer.
9. What is FDA Prior Notice and do Boston importers need to file it?
FDA Prior Notice under 21 CFR Part 1 Subpart I is required before every food shipment arrives — 8 hours for ocean (Port of Boston), 4 hours for air (Logan Airport), 2 hours for road. Must include the FDA registration number of the manufacturing facility and correct FDA product code. Errors cause port holds.
10. Does FDA Registration Assistance have a physical office in Boston?
FDA Registration Assistance is headquartered in Miami, Florida, and serves Boston and Massachusetts companies remotely. All FDA regulatory consulting — registrations, FSVP, label reviews, U.S. Agent services — is delivered remotely with full service to Boston-area clients.
11. What FDA services do Boston-area importers need?
Boston-area food importers typically need: Food Facility Registration for their own facility; FSVP for each foreign food supplier; Prior Notice accuracy review; food label compliance review; and U.S. Agent services if helping foreign manufacturers with FDA registration.
12. How does FDA Registration Assistance support Boston pharmaceutical companies?
Drug Establishment Registration under 21 CFR Part 207; U.S. Agent designation for foreign drug establishments supplying Boston companies; drug listing assistance; and FDA regulatory consulting. Boston’s Kendall Square and Greater Cambridge biotech cluster have significant drug establishment registration needs.
13. What are the FDA labeling requirements for food products sold by Massachusetts companies?
Under 21 CFR Part 101: statement of identity; net quantity; Nutrition Facts in 2020 FDA format with correct U.S. RACC; complete ingredient list; allergen declarations for all nine FALCPA/FASTER Act allergens including sesame (January 2023); and manufacturer or distributor name and U.S. address. All required text in English.
14. Do foreign companies exporting to Boston need a U.S. Agent?
Yes. Foreign food, drug, device, and cosmetics facilities exporting to the United States — including to Boston-area importers — must designate a U.S. Agent with a physical U.S. address as part of their FDA registration. FDA Registration Assistance provides U.S. Agent services for foreign companies exporting to Boston.
15. What is the FDA drug establishment registration requirement for Massachusetts pharmaceutical companies?
Under 21 CFR Part 207, pharmaceutical establishments in Massachusetts that manufacture, prepare, or process drug products must register annually (October 1–December 31) and list all marketed drug products with FDA. Failure to register is a prohibited act under 21 U.S.C. § 331.
16. Do Massachusetts food companies need to update their FDA registration when they add new products?
The registration must be updated within 60 days under 21 CFR 1.234 when food product categories manufactured at the facility change. A Massachusetts food company beginning a new food category — adding dietary supplement production, for example — must update its FDA Food Facility Registration within 60 days.
17. What FDA compliance issues are most common for Boston-area food companies?
Most common: failing to register before distribution; missing the Biennial Renewal (October 1–December 31 of even years); inadequate FSVP for imported food; missing sesame allergen declaration (FASTER Act, January 2023); Nutrition Facts in pre-2020 format or with wrong RACC serving sizes; and Prior Notice errors causing port holds.
18. Do Boston-area companies importing medical devices need FDA compliance support?
Yes. Companies importing medical devices must ensure foreign device manufacturers are registered under 21 CFR Part 807. FDA Registration Assistance verifies foreign medical device establishment registration status and assists foreign manufacturers in registering and designating U.S. Agents for Boston-area device importers.
19. How does FDA Registration Assistance help Massachusetts cosmetics companies with MoCRA?
MoCRA facility registration, product listing, U.S. Agent designation for foreign cosmetics suppliers, serious adverse event reporting guidance, and ongoing MoCRA compliance management for Massachusetts cosmetics companies. Annual renewal required for all registered facilities and product listings.
20. What is the FDA Biennial Renewal and does it apply to Boston companies?
Food Facility Registration renews every two years — October 1–December 31 of even-numbered years. Drug and device establishment registrations renew annually (October 1–December 31). Missing any renewal causes automatic cancellation. FDA Registration Assistance manages all renewal obligations for Boston-area clients.
21. Can Boston-area companies get FDA consulting services remotely?
Yes. All FDA Registration Assistance services are available remotely to Boston and Massachusetts companies. FDA registration submissions, FSVP programs, label reviews, and U.S. Agent services do not require in-person meetings. Full-service FDA compliance support is delivered remotely.
22. What is the Port of Boston’s role in FDA food import compliance?
The Port of Boston (Conley Terminal) is a significant U.S. food import entry point for New England. FDA has regulatory authority over all food imported through Boston. Food importers must file Prior Notice before each shipment, ensure foreign suppliers are FDA-registered, and maintain FSVP programs. Logan Airport is also a significant food import point for Boston-area air cargo.
23. Does Massachusetts have state-level FDA-equivalent regulations?
Massachusetts has state-level food safety and drug regulations administered by the Massachusetts Department of Public Health (DPH) and the Massachusetts Department of Agricultural Resources. These are separate from and do not substitute for federal FDA regulatory requirements. Boston-area companies must comply with both federal FDA requirements and applicable Massachusetts state requirements independently.
24. How does FDA Registration Assistance serve the Greater Boston area?
FDA Registration Assistance serves all companies across the Greater Boston area — Boston proper, Cambridge, Somerville, Quincy, Brookline, Newton, Waltham, Woburn, Lexington, and the broader Massachusetts market — across all FDA-regulated product categories. 1,000+ clients. 135+ countries. 15+ years of FDA regulatory experience.
25. How do I contact FDA Registration Assistance for Boston, Massachusetts FDA consulting?
Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Provide your company name, Massachusetts location, the FDA-regulated product category, and your specific compliance need. All services available remotely to Boston and Massachusetts companies.
