Enhanced Approach to Method Development Meets Regulatory Expectations and Provides Added-Value to Clients
At Tepnel, we have over 40 years of experience in the pharmaceutical field. Focussing on analytical testing such as lot and batch release testing, raw materials testing, method development and stability testing and storage. We have and always will strive to provide high quality services, and we show this by our continuous investment by hiring skilled workers and acquiring state of the art equipment. We endeavour to streamline all of our approaches for your analytical needs to achieve faster turnarounds through-out your drugs life cycle. We are committed to providing support that’s grounded on the promise of accountability, affordability and adaptability.
With this in mind, we are eager to discuss ways in which we can showcase our unwavering dedication to our clients and their requirements. Our adoption of AQbD concepts and Waters ACQUITY UPLC method development system enables us to do so. Subsequently, this amalgamation has successfully reduced method development turnaround by 30-50% (depending on complexity) and therefore accelerating the time your drug reaches the market.
Recently, we have been challenged to design methods to analyse complex mixtures; in many instances methods for such mixtures were non-existent or were not fit for purpose and therefore needed validating in line with GMP/ICH requirements. Even though, peptides are known for being difficult substances to separate, we welcomely accepted the challenge. We are delighted to present to you, two case studies in which we overcame any difficulties that are inevitably associated with such mixtures and to highlight the overall benefit to our customers for choosing Tepnel.
Contact us today to find out how we can support you with method development
You may also be interested in:
API and Finished Product
Large Molecule Formulations
Potency, Purity, Stability indicating
