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Recent Projects
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.
Medical Devices
FDA applications and registrations of various medical devices and label creation.
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 rehabilitation medical equipment.
Consultation on insurance reimbursement systems and applications for new medical equipment.
Selection of Clinical Research Organization for new medical device clinical trials.
Advisory services to sponsor organization for clinical trials.
Presentation of research reports on news releases on new medical devices.
Product introduction to university research institutions, coordinating with the academic opinion leaders.
Consultation of FDA registration/application of biochemistry 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.
Support for comprehensive marketing promotion for new medical devices in the U.S. in partnership with a trading company.
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.
Consultation on the product code of various medical equipment
Support for promotion at Trade Shows.
Finding distributors and assisting with distribution agreement.
Coordinating seminars
Food
Consultations on FDA, USDA, CDFA (California Department of Food & Agriculture) applicable regulations for various food manufacturing companies.
Consultation on the import of various instant foods
Consultation and reviews on food labeling.
Consultation of FDA regulation of new health food.
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 health food
Applications and registrations on Acidified/Low-Acid Food Canning Establishment (LA/LACF Form 2541) and Process Filing (Form 2541a and Form 2541c)
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) - Verification of seafood import
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.
Cosmetics
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 methods in the United States.
Research of Latin America cosmetics regulations.
GMP related consulting for cosmetics manufacturing facility.
Risk analysis of FDA regulations of hair color agent.
Pharmaceutical
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 company for direct food contact substance and indirect contact substance - FDA registration/application
FDA regulatory advise for a chemical company for food additives and consultation on CODEX
FDA registration/application of direct contact substance to pharmaceutical products for adhesive company.
Consultation for chemical 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
Supplements
FDA application and registration of various new 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.
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)
Others
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.