Our Drug Product Development Platform
From start-up to scale-up, our extensive experience allows us to seamlessly bridge the gap between the API and final product manufacturing. Our oral solid dose development platform is built on four integrated areas of expertise:
Formulation Development
Our work often begins with product evaluation and feasibility assessment, helping identify formulation strategies and potential development risks early.
With broad experience across a range of dosage forms, we combine multidisciplinary knowledge with hands-on problem-solving to resolve challenges as soon as they arise. Our formulation design approach considers critical factors such as bioavailability, stability and manufacturing scalability.
From reverse engineering and early research through formulation development and GMP batch manufacturing, we are dedicated to accelerating your product’s journey to market.
Advanced Drug Product Analytics
Our analytical laboratory provides comprehensive analytical services critical to successful drug development. From complex product analysis to method development and troubleshooting, we deliver the insight needed at every stage of development.
Using state-of-the-art techniques, including chromatography, spectroscopy, mass spectrometry and more, our expert team ensures your products meet the highest standards for quality, safety and efficacy.
As programs advance toward manufacturing, we support analytical testing, method transfer and stability studies, ensuring a smooth transition into routine quality control.
Excipient Characterisation
Excipients are essential to pharmaceutical formulations, influencing everything from stability to bioavailability. However, since many excipients are derived from natural sources, they often exhibit variability in purity, reactivity and functionality across different suppliers and even between batches. These inconsistencies can make it challenging to maintain control over product performance and safety.
Ofichem’s excipient characterisation platform ensures your excipients are right for your product. Our expertise, combined with advanced analytical methods, helps identify critical material properties and supports consistent product quality, safeguarding efficacy and stability.
Dissolution Testing
At Ofichem, dissolution testing isn’t just a routine procedure, but an essential tool for guiding pharmaceutical formulation development. Our teams integrate dissolution testing with development discussions and clinical data to support smarter, more effective decisions.
We specialise in predictive and biorelevant dissolution methods, enabling our customers to better understand product performance and proceed with clinical testing with confidence.
These four tightly integrated platforms reduce development risk and keep timelines efficient, helping you progress from formulation design to manufacturing with clarity and confidence.
Partner with Ofichem to streamline your drug development process and achieve faster, more reliable outcomes.
Clinical Trial Materials
With extensive experience in formulation development and over 30 years of drug product manufacturing expertise, Ofichem is the right partner to provide clinical trial materials in tablet, powder and granulate forms.
We support Phase 2 and Phase 3 clinical studies and can efficiently transition successful programs to commercial supply. By keeping development knowledge and manufacturing capabilities within one organisation, we help minimise technology-transfer risks and save time and costs.
We also support clinical packaging and supply preparation, ensuring materials are ready for clinical studies and regulatory submission.
