Our regulatory team at tranScrip offers comprehensive solutions to ensure successful agency dialogue, meticulous regulatory strategy planning, and timely submissions and approvals. Whatever your regulatory needs, we're here to help.
In the dynamic world of drug development, understanding and adapting to ever-changing regulatory demands is crucial. At tranScrip, our regulatory experts leverage their intimate knowledge of global and local regulations to provide our clients with effective support.
We approach every project holistically, specialising in regulatory affairs, quality systems, and compliance for a variety of products, including New Chemical Entities (NCEs), known drug substances, medical devices, in-vitro diagnostics, and drug-device combinations. Our team is proficient in handling both small molecule and large molecule biologics, including advanced therapy products that incorporate specialist delivery platforms or companion diagnostics.
Our dedicated experts are here to support and advise you on meeting your regulatory obligations. From maximising the outputs of your stakeholder agency dialogues to smoothing your product’s assessment journey, our specialists are on your side.
Maximise the value of your products with our bespoke solutions.
We help you develop and optimise your regulatory strategy, ensuring effective communication with regulatory agencies throughout the development process.
Our team provides comprehensive oversight for your clinical trials or clinical investigations, ensuring regulatory compliance at every stage.
We provide expert technical input and author regulatory documents for medicines, medical devices, and combination products.
We assist in integrating advanced delivery platforms and companion diagnostics into your product development process.
Our team manages the entire regulatory submission process, ensuring timely and accurate submissions.
We help you maintain compliance with all regulatory requirements and ensure your quality systems are robust and effective.
We provide support during agency audits, helping you navigate and comply with regulatory scrutiny.
Our Regulatory Affairs team is equipped to help you achieve successful regulatory submissions and approvals, whether it’s for a first-in-man study, a new product application, a renewal, or a label extension.
With a wealth of industry experience and a proven track record, we deliver exceptional results consistently. We seamlessly integrate with our clients as an extension of their team offering flexible, bespoke resources swiftly to adapt to evolving needs.
Our experienced physicians and scientists, together with our regulatory, clinical and commercial experts can support you to maximise the value of your products. Whatever your project requires, we have the expertise to meet your needs.
