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Summit Life Science is proud of the programs we offer. Nothing is more satisfying than watching our program implemented to help  improve the overall health of human being.

       

 Programs include:

  • Phytochemical Screening
  • Regulatory Services

"The improver of natural science absolutely refuses to acknowledge authority, as such. For him, scepticism is the highest of duties: blind faith the one unpardonable sin."
— Thomas Henry Huxley

  • Formulation R&D

I. Liquid Formulation

        1) SEDDS products design

        2) Liposome products design

    

II. Solid Formulation

        1) Control-release with/without functional film coatings

        2) Sustained-release, enteric release, colonic release

        3) Microencapsulation beadlets

   

III. Patch, Film and Cream Formulation

        1) Transdermal Patch products design

        2) Oral Thin Film products design

        3) Creams and Ointments products design

 

IV. Analytical Testings

      i). Physical Analysis

              Particle size distribution, Density, Flow ability, Color analysis, Taste analysis

    

      ii). Chemical Analysis

              Assay, Solvents, Pesticides, Impurities, Crystal form, Chemical structure analysis, Amino Acid Profile Analysis,                     PDCAAS evaluation

   

       iii). Heavy Metal Analysis

             Pb, Cd, As, Hg, and total heavy metal testing

    

       iv). Identification Analysis

             Species ID fingerprint analysis versus standard for confirmation, DNA testing for natural ingredients and finish                  products

  • Process Development

I. Milling, Sieving, Blending


II. Wet granulation, Roll compacting

 

III. Enteric/Time-release clear or color coating

 

IV. Tableting, Capsulation, Stick Pack, Pouch, Jar

 

V. Microencapsulation

 

VI. Liquid formulations

  • Regulatory Services
  • Formulation R&D
  • Process Development
  • Phytochemical Screening

I. Phytochemical Program Overview

II. Phytochemical In Vitro Study Platform

III. Phytochemical Animal Study & Clinical Trial Platform

I. FDA documents filing: GRAS, NDI, NDC, IND, ANDA


II. FDA certificates application: Food Facility Registration, Free Sale Certificate

 

III. USDA permits application: Veterinary Permit

 

IV. GMP compliance consulting

  • IP & Licensing
  • IP & Licensing

I. Intellectual Property: trademark & patent filing, domain application


II. Licensing: intellectual property licensing in and out

  • NDI, NCE, NME Development

Our R&D group can help customers develop the New Dietary Ingredients (NDI), New Chemical Entity (NCE) and New Molecular Entity (NME) through chemical synthesis process, Fermentation process, or Extraction process, or Enzymatic process.

     

  1. New Dietary Ingredients (NDI) is the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that require manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration about these ingredients.

  2. A New Chemical Entity (NCE) is, according to the U.S. Food and Drug Administration, a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.[1]

  3. A New Molecular Entity (NME) is a drug that contains an active moiety that has never been approved by the FDA or marketed in the US.[2]