Medical Writing
Apotech has a comprehensive range of services related to regulatory writing and support for both clinical and nonclinical development. These services cover various aspects of regulatory submissions, documentation, and compliance across different regulatory authorities.
Regulatory Writing Support:
- Tailoring support based on submission type and regulatory authority requirements
Nonclinical & Clinical Documentation:
- Clinical Study Report (CSR)
- eCTD Modules 2.4, 2.5, 2.6, and 2.7
- eCTD Modules 4 and 5
Clinical Trial Support:
- Clinical Trial Protocol (CTP)
- Investigator Brochure (IB)
- Efficacy and safety summaries
- Patient/safety narrative writing
Integrated Summaries:
- Support on Integrated Summaries (ISS, ISE, and ISI)
Scientific Writing Services:
- Publication, abstract, poster, brochure, presentation preparation
- Literature searches and reviews
Toxicological Risk Assessment:
- Assessment of impurities, extractables & leachables, excipients, and industrial chemicals
- Occupational Exposure Level (OEL) calculations
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FAQs
We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Our team has extensive experience in Advanced Therapy Medicinal Product (ATMP) clinical development and is well-versed in how to deliver compliance throughout the development process. Get in touch with us for further information.
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