Services

Orphanion’s Contract Research and Manufacturing Services derive their strength through careful selection of highly qualified contract developers/manufacturers from India and China.

Orphanion provides pharmaceutical manufacturing at varied scales, a deep understanding of complex chemistry, and a full compliance with guidelines of leading regulatory authorities, like FDA and EDQM.

The added value for our clients lies in our lean and virtual organisation, which results in competitive advantages in cost and timelines. Orphanion offers Custom Synthesis Services involving rapid scale-up of compounds, from milligrams up to multi-kilo scale (non-GMP/cGMP).

Specifically, the services include scale-up, process-development and optimization, process-validation, analytical method-development and validation, and impurity profile studies.

 Customer Support Services include material supply and documentation  for IND filing (CMC part of the IND).