SERVICES
New Century's services include serving the industries of medical devices, foods, health foods, nutracenticals, drugs and cosmetic products:

(1) REGULATION SERVICE:

  • FDA facility and product registration for food, drug and medical device.
  • Acts as U.S. Agent for foreign companies.
  • CGMP for dietary supplements / OTC drugs, GMP for foods
  • FDA / USDA regulation compliance (Various USDA permit / FDA certificates)
  • FDA pre-market approval / notification / OTC drug registration / Medical Device approval (PMA, PMN, IND 510k, etc) and licenses / certificates from state of California
  • FDA manufacturing certificate / GMP audit / Validation / OSHA regulation compliance
  • Product label / product advertisement / claims
  • Quality systems, HACCP, Food safety, GMP, and Recall.

(2) TECHNICAL SERVICE:

  • Product safety evaluation.   
  • Formulation and Product development.
  • Technology transfer
 

(3) MARKETING SERVICE:
 
  • Help to search ideal U.S. distributors for foreign companies, also provide marketing and marketing research consulting services.
  • CHINA RUSH - Help U. S. company to expand business in China
  • Trademark / patents / Copyright / Barcode / UL application
  • Translation / Interpretation


新世紀公司提供以下有關醫療器材, 食品、健康食品、保健產品、藥物、及化妝品的認証諮詢顧問:

(1)    法令服務  
  •  美國FDA設施及產品登記, 受聘替外國公司做駐美代理
  •  保健產品,藥物的 CGMP及食品的 GMP
  • FDA / USDA法令 ( 各種USDA 批准PERMIT / FDA 証件)
  •  FDA 銷售 / 進口前批准, OTC 藥品註冊 / 醫療設備審批(PMA, PMN, IND, 510K 等 ) 加州政府証件
  • FDA 製造許可證 / GMP 審核  / OSHA 法規
  • 產品標籖 / 產品廣告/ (CLAIM)用詞
  •  GMP, 優良產品製造規範  / HACCP / 食品安全 / 產品召回

(2)    技術服務    
  • 產品安全評估
  • 研究發展方案 / 配方與產品研究
  •  技術轉移

(3)    市場服務

  • 替外國公司物色經銷商及提供經銷市場的諮詢顧問
  •  商標 / 專利 / 版權 / 條碼 / UL申請
  • 協助美國 公司擴大在中國業務
  • 筆譯 / 口譯


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