Situation: Our client purchased the rights to an orphan drug with the stipulation that the product could not be manufactured at the original site.

Task: Facing marginal inventories and limited existing API...

Situation: Our client was faced with regulatory commitments and shifting product lines in their manufacturing facilities. This situation produced a critical GMP compliant accelerated demand for analytical testing. Product supply...

Situation: The client wished to accelerate the timeline of developing an extended release dual active solid oral formulation, which required a major change in their development approach. A wide array of excipients were under...

Situation: Our client was operating multiple manufacturing sites which had not qualified their cleaning disinfectants to FDA requirements, and as a result were under a consent decree to complete these qualifications within a year...

Situation: Our client needed a method developed to monitor the levels of a key component of an adjuvant in their vaccine product. The adjuvant component was a high molecular weight polymeric compound with no UV chromophore. The...

Situation: The client requested three strengths of immediate release capsules for a blinded study using a drug with extremely poor solubility across the pH range. In addition, a simple dry blend method of manufacture in...

Situation: Our client needed assay, related substance and dissolution method development to support the reformulation of two different extended release tablet formulations each containing three different actives (total of four...

Situation: Our client requested a taste masking study to mask the taste of their drug as an oral powder for reconstitution as a suspension. The challenge was to provide a fast, aqueous dispersible vehicle that would not only be...