Peptides for Nuclear Medicine
piCHEM develops and provides a wide range of molecules which are utilised as precursors for radiopharmaceuticals.
Precursors are used for:
- Targeted tumor diagnosis and therapy
- Non invasive examinations
- Receptor scintigraphy and therapy (PET)
- Development of cold kits
- Reference substances
- Development of new targeting molecules in close collaboration with radiopharmacy departments and nuclear medicine centers
piCHEM is manufacturer of various peptides in the field of nuclear medicine and provides appropriate Chemistry, Manufacturing and Control (CMC) regulatory documents.
These documents contain important information and details of the production process to enable the competent authorities (including but not limited to EMA and FDA) to assess the manufacturing and control of the peptide. piCHEM will issue a letter of access (LoA) to allow relevant authorities to review the documents.
piCHEM actually holds DMF/ASMF for active ingredients:
HYNIC-TOC (INN not assigned)
piCHEM has a large expertise in filing regulatory documents for new chemical entities used in clinical trials and will support your submission in many countries throughout the world.