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      Details

      FDA. ISO. EU and CE regulatory affairs & quality assurance medical device consulting.

      General Info

      JB & associates includes regulatory compliance consultants. Engineers and healthcare professionals. We serve many segments of the healthcare industry with emphasis on medical devices. Pharmaceuticals. Biotechnology. Clinical diagnostics and dietary supplements. We Also serve general industrial clients with ISO regulatory compliance and certification. OUR regulatory process services address each phase of a Product’s life cycle from conception. Through design. Development. Clinical trials. Regulatory approvals. Market introduction. Sales. Distribution. Manufacturing and ongoing management. We offer a wide range of services throughout each phase. Industries serving the following life science and healthcare related industries: biotechnology. Biological research. Gene therapy clinical diagnostics. Clinical labs and diagnostic instrumentation cosmetics dietary supplements. Alternative medicine. Natural/herbal therapies and BOTANICALS hospitals and healthcare facilities in vitro diagnostics (IVD) laboratories (biological research. Clinical. ETC. ) medical device manufacturing: class I. II. III medical DISPOSABLES and surgical instruments. Specialties include urology. Cardiology. Ophthalmology and neurology. Pharmaceuticals and generic drugs US government (FDA. Usda) and state regulations (California. ETC) International: EU (ISO standards and CE marking) and asia (china. India and japan). SERVING THE FOLLOWING LIFE SCIENCE AND HEALTHCARE RELATED INDUSTRIES: Biotechnology, Biological Research, Gene Therapy Clinical Diagnostics, Clinical Labs and Diagnostic Instrumentation Cosmetics Dietary Supplements, Alternative Medicine, Natural/Herbal Therapies and Botanicals Hospitals and Healthcare Facilities In Vitro Diagnostics (IVD) Laboratories (Biological Research, Clinical, etc.) Medical Device Manufacturing: Class I, II, III Medical Disposables and Surgical Instruments. Specialties include urology, cardiology, ophthalmology and neurology. Pharmaceuticals and generic drugs US Government (FDA, USDA) and State Regulations (California, etc) International: EU (ISO Standards and CE Marking) and Asia (China, India and Japan)

      HoursOPEN NOW
      Regular Hours:
      Mon - Sat

      Contact Info

      Phone:

      Main - 949-433-3058

      Extra - 949-374-1950

      Address:
      24551 Del Prado Dana Point, CA 92629
      Email:

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      Categories
      Medical Service Organizations, Business & Trade Organizations, Business Coaches & Consultants, Business Forms & Systems, Business Plans Development, Import Representatives, Medical Business Administration, Medical Equipment & Supplies, Quality Control & Consultants, Records Management Consulting & Service
      Payment Options
      paypal, financing available, check
      Location
      Based in California, we assist domestic firms throughout the US, as well as international clients mainly in Europe and Asia (China). We work with government agencies, public and private research institutes, laboratories and industry. Learn more by explori
      Associations
      ASQ,EU,FDA,GMP,ISO,RAPs,US
      Suggest an Edit
      Data provided by one or more of the following: Thryv, Data Axle, Yext.