Index

CLIENT SERVICES

We have amassed an unparalleled level of expertise in this complex field and endeavours to offer a 'one stop shop' service to clients developing prostaglandin drug products. Our aim is to work closely with our clients to efficiently develop prostaglandin drug products. Our services include:

The development of enhanced stability semi-formulations such as excipient-powder and wax dispersions and cyclodextrin complexes
Stability studies on raw material and formulated products
Analytical methods development for API and some formulated products
Provision of degradents, impurities, isomers and metabolites
Contacts with CROs and development companies with relevant experience in stability studies bio-equivalence studies and formulation development with PGs
Comprehensive product dossiers (technical packages), regulatory documentation and drug master files (DMFs)

Custom Synthesis, Process Development, Scale-Up & Manufacturing

The company also offers chemical process development and custom manufacturing for prostaglandin and related complex high value molecules required for toxicology/clinical investigations, formulation development and drug product manufacture.

Our chemists have in depth experience, amassed over many years in 'big pharma' and in-house, in the development of prostaglandin active pharmaceutical ingredients (APIs). We offer synthetic route identification, process development and scale up, under cGMP, for new (NCE) and established prostaglandins (and other related complex molecules) required for toxicology, clinical investigations, formulation process development and ultimately drug product manufacture. Where a client has an existing chemical synthesis our chemists can utilise this as the starting point for development and scale up as required. A number of other complimentary services such as analytical methods development can be offered alongside custom synthesis.