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ElixinPharma Pharmaceutical and Biotechnology Consultants
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Welcome

We are an independent consulting firm dedicated to assisting emerging and established pharmaceutical companies with Chemistry, Manufacturing and Controls (CMC) challenges. We also provide assistance in the writing and defense of CMC sections of regulatory applications ranging from small molecules to larger macromolecules such as oligonucleotides. We have unique expertise in the development of oligonucleotide-based therapeutics and diagnostics.

Experienced in the development of:
  • Small molecules
  • Antisense oligonucleotides
  • Immunostimulatory oligonucleotides
  • DNA decoys (DNA duplexes)
  • siRNA (RNA duplexes)
  • Ribozymes
  • Aptamers
  • PEGylated compounds (Including aptamers)
  • Other oligonucleotide conjugates
  • Oligonucleotides in complex dosage forms (oral, pulmonary, intravitreal, topical, liposomes, nanoparticles, microspheres)
  • Dendrimers

Oligonucleotide regulatory experience:

  • US FDA (most divisions)
  • Canada
  • Europe: EMEA, France, Germany, Italy, Spain, Sweden, The Netherlands and UK
  • Israel
  • South America
  • Australia
  • Japan
 
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