Complete Services & Extensive Experience
CoreRx™ offers comprehensive drug product development services to the pharmaceutical and biotechnology industries. Supporting virtual, mid-size, and multinational companies, CoreRx offers customized formulation development and clinical material manufacturing solutions.
Our solutions optimize client investments, shorten development time and reduce overall costs. From first-in-man drug development to full cGMP manufacturing support, CoreRx combines 200+ years of combined pharmaceutical development expertise to produce safe, effective, and innovative drug products, on time, and on budget.
Compatibility studies, prototype evaluations and chemical property determinations performed to support your pre-clinical platforms including: pH solubility profiles, pKa determinations, polymorphism studies, API-excipient interactions, salt selection, hygroscopicity studies, and determination of distribution/partition coefficients.
Read more: Pre-Formulation
Our process allows for timely execution of formulation development from lab scale prototypes to clinical trial materials. This process ensures speed to the market with proven results for the following: API in capsules or bottles, tablets, capsules, oral liquids, parenterals (solutions, suspensions, and lyophilization), semi-solids, etc.
Read more: Formulation Development
The CoreRx Facility was designed to provide pharmaceutical and biopharmaceutical companies with a quality resource for the cGMP manufacture of oral liquids, oral solids, topicals, and other Clinical Trial Materials (CTM) for Phase I/II studies. The CoreRx facility also offers primary and secondary packaging services for solid, semi-solid, and oral liquid dosage forms, including over encapsulation.
Read more: Clinical Manufacturing
Analytical methods can be developed and validated for drug substances and finished product. We support development and validation of methods for stability-indicating properties, purity, potency, dissolution, cleaning verification, impurity profile, and others.
Read more: Analytical Development
To support your fast-track clinical programs, CoreRx can produce API/drug substance in bottle supplies, as well as blended API in capsules. CoreRx can move quickly and efficiently to meet your clinical timelines.
Read more: First-in-Man Studies
CoreRx offers diversified technical resources, capacity, flexibility, and the experience to develop and manufacture virtually any clinical dosage form with strict quality compliance. We partner with you to provide expert scientific resources throughout the manufacturing process.
Read more: Contract Manufacturing
CoreRx offers comprehensive stability services. Whether a drug substance or final product is in development or already on the market, CoreRx can fulfill stability storage and testing requirements.
Read more: Stability Services