25 years and counting!
Founded in 1999, we are a scientific and regulatory consulting firm dedicated to assisting emerging and established pharmaceutical companies with Chemistry, Manufacturing and Controls (CMC) challenges of novel technologies. We also provide assistance in the writing and defense of CMC sections of regulatory applications ranging from small to macromolecules. 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)
- microRNA
- Ribozymes
- Aptamers
- PEGylated aptamers
- Oligonucleotide conjugates including GalNAc
- Oligonucleotides in complex dosage forms (oral, pulmonary, intravitreal, topical, liposomes, nanoparticles, microspheres)
- Dendrimers
Oligonucleotide regulatory experience:
- US FDA (most divisions)
- Canada
- UK
- Europe: EMA, France, Germany, Italy, Spain, Sweden, The Netherlands
- Eastern Europe
- Israel
- South America
- Australia
- Japan
- China