We provide consulting services to a wide range of clients, from multi-national large public companies, mid-sized companies with long successful history and also venture companies with new products that are coming to market. We provide support with respect to FDA applications and registrations, regulatory advice, patents and trademark applications and various other areas of strategic advice. We also assist companies to develop a business plan and provide ongoing support to help ensure company's success.
FDA applications (510K and Pre-Submission) and registrations of various medical devices.
Classification and determining Product Codes for various medical devices.
Support preparation for Informational Meeting and Pre-Submission for new medical device; negotiation with the FDA regarding the appropriate application process.
Consultation on new medical device development, research on regulatory requirements and risk associated with the sales of such device in the U.S.
Regulatory consultation regarding the design and development of new medical equipment.
Consultation on insurance reimbursement systems and applications for new medical equipment.
Coordination with the FDA PCTF（Payor Communication Task Force）for potential insurance coverage for new medical devices.
Business plan for a new medical device product, including recommendation for pricing strategy, finding partners and analysis of the current dynamics of medical device industry.
Support for comprehensive marketing promotion for new medical devices in the U.S. in partnership with a trading company.
Selection of Clinical Research Organization for new medical device clinical trials.
Advisory services to sponsor organization for clinical trials.
Product introduction to university research institutions and coordinating with academic opinion leaders.
Consultation of FDA registration/application of biochemical medical equipment.
FDA registration application for drug administration medical device.
Regulatory clarification of oral care products.
Patent application and registrations of new products
Trademark application and registration for a new medical device.
Coordination with investors on new medical devices after FDA approvals and registrations and support of marketing and promotion in the United States.
Contract manufacturing in China of new medical devices developed in Japan.
Support promotion at Trade Shows.
Finding distributors and assisting with distribution agreement.
Resolving issues when medical devices are detained by the FDA.
Collaboration with IRB for clinical trials on medical devices for the US market
Consultation on compliance for medical devices
Support partner selection after FDA clearance & approval for new type of medical device.
Consultation on Prop. 65 of various medical devices
Consultations on federal and state level applicable regulations such as FDA, USDA, CDFA (California Department of Food & Agriculture) for various food categories including fishery products, fishery processed products, livestock meat, rice, vegetables and fruits, cut flowers, alcohols, condiments, tea and confectionaries.
Consultation and support on preparation for FSMA (Food Safety Modernization Act)
Consultation and support on FSVP (Foreign Supplier Verification Program)
Consultation and support on HACCP (Hazard Analysis on Critical Control Point）
Consultation and reviews on food labeling.
Consultation on compliance for FDA and other applicable regulations for new health foods.
Application to be listed on Green List for vacuum packed fishery products.
Advisory on compliance on Prop. 65
Consultation on Organic labels
Resolving issues when various foods are detained by the FDA
Applications and registrations on Acidified/Low-Acid Food Canning Establishment (LA/LACF Form 2541) and Process Filing (Form 2541a and Form 2541c)
Support on commercialization on low acid and acidified canned foods
Investigation of the methods for analysis and measurement of the nutritional value defined in FDA regulation
Regulatory application of food manufacturing facilities associated with new product development (California Department of Food and Agriculture)
Consultation of Clinical Observations, joint work with U.S. university research institutions and CRO (Clinical research organization)
Consultation on patent acquisition procedure of new health food
Consultation on importation of various meat and eggs ingredients
Pertaining to establishment of new food factory, clarification of regulatory requirements, at the federal, state, county and municipal level (Texas )
Pertaining to establishment of new food factory, clarification of regulatory requirements, at the federal, state, county and municipal level (California)
Research on countries on allergy-related warning
The investigation of the label regulations on other countries
Consultation on regulations on oil and fat products
Consultation on GRAS notification and FIP (Food Ingredient Petition) of oil and fat products
Various Seafood HACCP-related consultations (Hazard Analysis Critical Control Point)
Resolution of Import alerts issues - various seafoods
Consultation of how to sell new vitamins as medical foods
Consultation on the import of Bakery Goods ingredients
Color Additive Petition
Research and identification of contract manufacturing facilities for various foods and beverages
Research of regulations for various new food ingredients at federal and state levels
Consultation on formulation on food and beverages for the U.S.
Prop. 65 consultation for various foods and beverages
Various cosmetics ingredients checks (hair care, skin care, UV foundations, hair color, aroma oil, nail care products and many others) labeling check against applied regulations, FDA, (CSCP)California Safe Cosmetic Program, EPA(Environmental Protection Agency) and CARB (California Air Resource Board) regulations
FDA registrations, CSCP, EPA and CARB reporting.
Consultation for Canadian cosmetics import regulations.
Cosmetic-drug registration (sunscreen containing cosmetics, toothpaste with fluoride)
Cosmetics products re-formulation to be compliant with US regulations
Cosmetic products re-formulation to be catered toward U.S. market.
Risk analysis of sales of various cosmetics in the United States.
The support for various cosmetics sales in the United States.
Consultation with the FDA about the U.S. import permit for the new cosmetics.
Consultation on regulations on a promotion method in the United States.
Labeling regulations on Organic product for cosmetics for federal level and state level
Research of Latin America cosmetics regulations.
GMP related consulting for cosmetics manufacturing facility.
Risk analysis of FDA regulations of hair color agent.
Consultation regarding comparison of USP and JP
Marketing support and application to FDA on drug dispenser
Electronic registration of over-the-counter- prescription drugs
Consultation for setting up chemical laboratory in the U.S.
Consultation on OTC drug recall regulations and practices
Food contact substance
Consultation for a chemical companies/trading companies for direct food contact substance and indirect contact substance - FDA registration/application
FDA regulatory advice for a chemical companies/trading companies for food additives and consultation on CODEX
FDA registration/application of direct contact substance to pharmaceutical products for adhesive company.
Consultation for chemical companies/trading companies on packaging materials and adhesive regulations for variety of usage.
Consultation for food processing companies on the import of food contact machine
Consultation for trading companies on import of variety of food contact substance
FDA applications for NDI(New Dietary Ingredient) and registration of various new dietary supplements and label creation.
Consultation on regulatory policies over product claims of various supplements.
Consultation on procedures to import various supplements.
Selection of distributors in the U.S. for sales of supplements. Advise on distribution agreement and execution of documentation.
Support on GMP compliance issues on Dietary Supplements manufacturing
Support on compliance issues on FSMA
Consultation on the application of patents for new type of supplements.
New types of liquid supplements - advice on FDA USDA regulations.
Applications and registrations on Acidified/Low-Acid Food Canning Establishment. (LA/LACF Form 2541) and Process Filing (Form 2541a and Form 2541c)
Resolving issues when dietary supplement products are detained by the FDA.
The problem-solving by taking appropriate measures to clear import alerts with goods that have been rejected by the United States customs.
Assist on emergency situations on Product Liability-related issues for cosmetics companies and medical device companies.
Investigation and compliance as to federal, state, county, city level environmental issues for factory construction.