tranScrip provides comprehensive regulatory strategic guidance and tactical support across the entire product development journey - from early development through marketing authorisation and post-approval stages. Our resolute team of experienced experts is committed to helping you formulate and implement robust regulatory strategies that maximise the value of products and expedite delivery for the benefit of patients worldwide.
Navigating the rapidly changing regulatory landscape is crucial for successful development and commercialisation of products. At tranScrip, our regulatory experts draw on extensive industry experience and a deep understanding of regulatory frameworks to address our clients’ unique needs.
We provide a comprehensive range of services, across the entire development and life-cycle stages, for regulatory strategy and tactical solutions. Our experts support a wide range of product development programmes, from small molecules and biologics to advanced therapies, specialised delivery platforms, and medical devices.
Our experienced teams are ready to partner with you in defining and implementing effective, innovative regulatory strategies that will optimise your product development strategy and facilitate an optimal return on investment whilst ensuring regulatory compliance.
Our team of highly qualified and experienced regulatory experts will guide you through every step of product development, commercialisation, and compliance.
We guide our clients to develop regulatory strategies that optimise success and return on investment. Combined with tranScrip’s medical, commercial and market access experts we provide a powerful solution. We stay up to date with the latest regulatory landscape, risks, and opportunities.
Our team has established connections with Health Authorities and industry networks, enabling us to devise and implement effective strategies. These include clinical development plans, guidance on special designations like orphan drug designation, PRIME, and Breakthrough designation, support for reliance approval pathways, expert support for Health Authority interactions for drugs and medical devices, paediatric development strategies, and much more.
Our experienced team is equipped to support all regulatory aspects of clinical trials worldwide. We offer strategic advice, assist with Clinical Trial Application (CTA) and Investigational New Drug (IND) submissions and amendments, and manage safety communications, end-of-trial processes, and other maintenance activities.
With especially deep insights into EU clinical trial regulatory submissions and the UK clinical trial environment, we are committed to ensuring that your trials remain fully compliant with all regulatory requirements. We also provide pragmatic and creative solutions to navigate any regulatory challenges that may arise.
Our team of highly skilled regulatory professionals is prepared to offer comprehensive strategic and operational support for all your regulatory Chemistry, Manufacturing, and Controls (CMC) needs. We provide services that encompass CMC development plans, gap analysis, and drug master files for all regions.
Additionally, we offer CMC support for IND, CTA, MAA, and NDA/BLA submissions, along with the authoring of technical documents and reports. Our expertise covers a wide range of development programmes, including small and large molecules, medical devices, and combination products.
Our experienced and dedicated medical writing team is here to support all your document writing needs. With a deep understanding of global structure and content requirements, our staff is meticulous in their approach to authoring. We work diligently to translate your data and content into documents that optimise your regulatory submissions and interactions.
We offer comprehensive authoring and content strategy services for various documents, including Investigator Brochures (IBs), Clinical Study Reports (CSRs), Protocols, medical device Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs) and IBs in addition to supportive documentation for Marketing Authorisation Applications (MAAs), New Drug Applications (NDAs), Biologics License Applications (BLAs), Clinical Trial Applications (CTAs), Investigational New Drug applications (INDs), as well as Orphan Drug and paediatric applications.
Our highly skilled team is dedicated to supporting your regulatory needs for medical devices at every stage of their product lifecycle, from development to post-marketing activities, on a global scale. We also provide expertise to help you meet regulatory requirements for drug delivery devices and companion diagnostics.
Our expert team is equipped to manage all your regulatory and submission publishing needs. We provide comprehensive support throughout the entire regulatory submission process, ensuring that all submissions are timely, accurate, and formatted to meet global regulatory requirements.
Our experts possess extensive knowledge of global regulatory compliance requirements and are equipped to support you in ensuring that your quality systems are both robust and effective. We support Quality Management System (QMS) set up and maintenance, gap assessments, inspection readiness activities, audits for drugs and medical devices. In addition, our experts can provide quality assurance management for Good Clinical Practices (GCP), Good Manufacturing Practices (GMP) and Good Pharmacovigilance Practices (GPPV).
Health Authority Audits and Notified Body Audits can be challenging, but our experienced and professional team is here to provide calm, reliable support every step of the way. Our goal is to simplify your audit journey, making it as seamless as possible. We provide comprehensive assistance, including conducting mock audits, helping you anticipate requirements, and preparing thoroughly. With a focus on ensuring compliance with global quality and regulatory standards, we guide you toward successful market access. Whether it’s the Medical Device Single Audit Program (MDSAP), ISO 13485, or CE marking, we are committed to your success.
Our team of seasoned regulatory experts is ready to partner with you, offering tactical support and strategic guidance throughout the entire product development process—from early product development to marketing authorisation and beyond. We combine technical expertise with innovative problem-solving to help you optimise product development and commercialisation for the ultimate benefit of patients.
With extensive industry experience and a proven track record, we consistently deliver exceptional results. We integrate seamlessly with our clients as an extension of their teams, providing flexible, tailored resources that quickly 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.
