MedPharm has led the way in pioneering this approach to generic drug product development. We support our clients by producing credible data and presenting reliable arguments to regulatory authorities during scientific advice and pre-ANDA meetings.
By maximising our deep understanding of the regulatory landscape and close relationships with the relevant bodies, we can interpret and stay abreast of changing guidelines.
Our approach ensures that the smallest dataset possible is generated to gain approval, with this strategy providing the most efficient path to progress your therapeutics to the clinic.
Unlike a typical contract research organisation, MedPharm acts as a partner to clients to ensure that they can benefit from our 20 years of technical experience. We provide comprehensive feedback on any project, as well as undertaking formal gap analyses. Moreover, we will offer candid advice if we believe any requests are unnecessary for a successful submission. The scientific integrity of MedPharm’s work is respected by regulatory authorities and inspires credibility and confidence in a client’s submission.
We are in frequent contact with regulatory authorities, who seek out our advice on topical formulation guidelines and request in-house training. We are the only contract research organisation whose scientists have been asked to speak at FDA-sponsored webinars.