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 drug product development platform is built up on four areas of expertise:
Formulation Development
With broad experience across a wide range of dosage forms, we combine a multidisciplinary approach with hands-on problem-solving, rolling up our sleeves to resolve challenges as soon as they arise. Our approach to formulation design takes into account factors such as bioavailability, stability and manufacturing scalability.
From reverse engineering, through in-depth research and development, up to GMP batch manufacturing, we are dedicated to accelerating your product’s journey to market.
Advanced Drug Product Analytics
Our analytical laboratory specialises in delivering comprehensive analytical services that are critical for successful drug development. From complex product to method development and troubleshooting, we offer the insight you need at every stage.
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. When your process is ready for scale-up, we handle the analytical method transfer, supporting seamless integration into final quality testing.
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 is designed to ensure your excipients are right for your product. Our expertise, combined with advanced analytical methods, helps identify critical properties to ensure consistent quality, safeguarding the efficacy and stability of your product.
Dissolution Testing
At Ofichem, dissolution testing isn’t just a routine procedure, but an essential tool in guiding pharmaceutical formulation development. Our teams integrate dissolution testing with development discussions and clinical data, guiding smarter, more effective decisions.
Our team is dedicated to developing advanced predictive and biorelevant methods, empowering you to make well-informed R&D choices. These sophisticated methods allow our customers to proceed with clinical testing with confidence.
These four tightly integrated platforms are designed to reduce risks and keep timelines tight, saving you time and energy. Partner with Ofichem to streamline your drug development process and achieve faster, more efficient outcomes.
Clinical Trial Materials
With extended knowledge of formulation development and over thirty years of drug product manufacturing experience, Ofichem is the right partner to provide clinical trial materials in tablets, powder and granulates.
We can be your ideal partner in Phase 2 and Phase 3 and with your study being successful, commercial scale up can be done in an efficient way by keeping knowledge in one location and using the same facility for the commercial supply, saving time and cost for a transfer.
