Scendea
WEBScendea is a leading product development and regulatory consulting group serving the pharmaceutical and biotechnology industry. We are committed problem solvers, redefining the meaning of customer service, with a focus on reducing time-to-market and minimising development costs.
About - Scendea
WEBWith origins dating back more than 20 years and involvement in over 1,000 development programs, Scendea is a rapidly growing product development and regulatory consultancy.
Services — Scendea
WEBWhether you require ad hoc assistance, a project-based solution or a dedicated outsourced team, Scendea can support your medicinal product development. Discover examples of our services below…. Speak to an expert.
Service Regulatory — Scendea
WEBScendea excels in representing you during critical meetings with the US-FDA, EU-EMA, UK-MHRA and other national authorities. Our team collaborates closely with you to optimise interactions, aligning your strategies with regulatory expectations for a more successful development journey.
News — Scendea
WEBRemain up-to-date with Scendea’s latest news, active conference schedule, and thought-leadership content.
Service CMC — Scendea
WEBAt Scendea, our capabilities encompass two fundamental services: the generation of CMC Development Plans and conducting thorough reviews of existing CMC Development Plans. Scendea takes a strategic approach to preparing CMC Development Plans, that address the specific needs of your product.
Service Clinical — Scendea
WEBAt Scendea, our expert team specialises in both high-level assessments and comprehensive deep dives. Our Due Diligence activities identify crucial gaps in Non-Clinical, CMC, and Clinical data, pinpointing potential risks that could hinder the progression of your projects in US, EU and UK markets.
Contact — Scendea
WEBScendea USA Inc. 4079 Governor Drive #5082 San Diego CA 92122. Tel: +1 619 793 4511
Expansion of Meetings with the US FDA — Scendea
WEBApr 23, 2024 · This paper will discuss the expansion of PDUFA meetings implemented by the FDA User Fee Reauthorisation Act of 2022 (PDUFA VII, 2023 – 2027) and provide a reflection on the relevance of Type D meetings and the expansion of INTERACT meetings based on Scendea’s collective experience since their implementation.
Orphan Drug Designation in the US, EU & GB — Scendea
WEBScendea’s expert consulting team has experience of obtaining orphan drug status in the EU, GB and US in a variety of challenging circumstances, and can advise companies on the data requirements, how best to position the available data, and how to use available data from the literature to support an application.