We take your concepts and turn them into generic drug opportunities through a robust development process for the United States, Canada, and Europe.

 

To accelerate your development pipeline, our team engages in a tested process methodology increasing product success, including:

 

• Pre-Formulation and material science: we investigate the chemical and physical properties of the Active Pharmaceutical Ingredient (API), excipients, and product and process contact components;

• API and Excipient Identification: we identify and help select the most appropriate active ingredients and excipients for our client’s products;

• Formulation Development: in arriving at the most robust formulation and process, the team carries out studies like sensitivity studies, sterilization method development, primary packaging determinations, process optimization, and, where necessary, preparation for bioequivalence studies for injectable or dermatological drugs or IVRT/Vasoconstriction studies for topical products;

• Process Development: Working directly with our contact manufacturing partners, we undertake a process review of the product and the supporting methods by testing different key process parameters in house prior to transfer, reducing risk in product scale up.

• Scale-up: Our team is actively involved in the technical transfer of the product to our contract manufacturing partner, ensuring that the product is cared for all the way through production.