We advance your clinical candidates through the pipeline quickly and safely with expert drug product services, whether you are looking for the development of a fit-for-purpose pre-clinical formulation or the manufacture of clinical trial material.
Science-led. Diligent. We guide you down the smartest path to meet your molecule’s milestones on time.
Our experts provide drug product services through dedicated analytical, formulation development, manufacturing and scientific reporting teams. Our integrated capabilities are uniquely engineered to enable early phase development and support you all the way to market.
Our fully equipped drug product development facility houses separate analytical and formulation development laboratories as well as GMP accredited manufacturing suites. Our quality GMP manufacturing suites have sophisticated systems that ensure your drug products meet the highest quality standards. The site also has a state-of-the-art warehousing facility and separate packaging and labeling areas.
In addition, our facility has several walk-in stability testing rooms operated in accordance with ICH recommendations and has continuous monitoring systems capable of monitoring samples in real-time, 24/7.
We de-risk your path to the clinic by providing the most detailed data available with comprehensive formulation characterization and analytical services.
We guide our customers into making smarter formulation choices. This reduces the risk of clinical failure and ensures your product reaches the clinic rapidly via the most efficient route.
Solving a problem and saving time, overcoming your development challenges is our specialty. We work with you to understand your product needs and develop the best possible formulation.
We have the capabilities to develop formulations for a broad range of administration routes, from oral and topical to intranasal, ocular and parenteral, and can handle highly potent compounds and controlled substances
Ensuring you have a complete understanding of product quality and stability is critical to the success of your drug development process
We offer a variety of analytical capabilities to support drug development, removing the need for additional partners and simplifying your supply chain.
Our areas of expertise include chromatography capabilities and dissolution studies, and we ensure that methods used for GMP analytical testing are validated according to ICH guidelines using a staged and phase-appropriate level.
Our product analytical services offering includes chromatography capabilities using state-of-the-art equipment.
Dissolution is a key quality attribute for a solid dosage form and needs to be kept in mind during pharmaceutical development.
Whether the dosage form is immediate release or modified release, we offer dissolution method development support, using state-of-the-art USP-1, USP-2 and USP-4 equipment.
Our dissolution testing services span all phases of drug development:
During drug development, the selection of the most effective formulation must be supported by effective biorelevant dissolution testing. It is important that the media used in these dissolution setups are representative of the human gastrointestinal fluids.
We have expertise in a broad range of biorelevant dissolution techniques including two-phase systems and flow-through methodologies.
From our facilities to our people, we are engineered to be top performers. We deliver consistent non-GMP and GMP drug product manufacturing services to the highest standards and to your timescales.
We can handle a variety of dosage forms including highly potent compounds and controlled substances with a specialism in small-scale batches.
Stability studies are an essential component of pharmaceutical development. We have the capabilities to evaluate drug stability in a range of environmental conditions with changes in humidity, temperature and light.
Our ICH-compliant stability storage facilities consist of over 100 m³ of walk-in stability rooms, fully secured with 24/7 electronic monitoring, alarm and backup power.
We can execute:
Our experts share their deep, scientific understanding and insights into drug product development and manufacturing.
Get in touch to see how we can craft your path to the clinic with dedicated capabilities.
Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.