- Vast global clinical trials experience
- Global Regulatory Leads offering strategic submissions planning
- Services for all stages, from drafting protocols to coordinating submissions
- Preparation of Clinical Trial Authorizations applications at global and local levels
- Country specialists with extensive local regulatory knowledge and cultural awareness
Clinical trials require continuous regulatory involvement and companies don’t always have the resources or experience in-house to provide the necessary input. By using Kendle’s Clinical Trial Regulatory Affairs group, your company will benefit from the experience we’ve gained in supporting clinical studies worldwide. Our regional knowledge enables us to provide high-quality regulatory packages tailored to a specific indication and market, minimizing regulatory agency questions and accelerating the approval process.
Not only does Kendle offer our experience, expertise and advice on submissions strategy and queries, we can perform all required study tasks, from writing of the protocol to delivery of the complete Trial Master File. On global studies we act as worldwide submissions coordinator, serving as an integral part of our customers’ study team from day one.
Our regulatory specialists work closely with the technical experts in our regional offices to prepare the specific regional authorizations required. In addition to knowing the language and culture, these local experts enable us to stay abreast of the evolving requirements of each individual country. We also channel local regulatory knowledge from these country specialists into a regularly-updated central repository, enabling our Global Regulatory Lead to plan the most effective submissions strategy for study success.
We recognize the importance of clear, concise information in investigator brochures and use medical writers and Chemistry, Manufacturing and Controls (CMC) and nonclinical experts to prepare this material.
We have extensive experience in preparation and submission of European Union Clinical Trial Applications (CTAs), including the Investigational Medicinal Product Dossier (IMPD).
As a full-service CRO, we offer fully integrated services, including global clinical development, biometrics, late phase and safety.
We are holders of a Manufacturer’s Authorization MA (IMP) for import and release of clinical study supplies into Europe, and can carry out this release for our customers.
We provide full writing, editing and technical document processing support for Investigational New Drug Applications (INDs). All IND sections are prepared and reviewed in accordance with 21 CFR § 312 and ICH guidance.
We draw on our experienced CMC, nonclinical and clinical experts for the preparation and submission of Clinical Trial Exemptions (CTXs) in Australia.
We use experts throughout Latin America and the Asia/Pacific region to ensure CTA regulatory packages meet the continuously-evolving and ever-increasing individual requirements of each country.
We offer a full medical writing service, using customer templates or our own. 
|
