Previously, we have discussed the importance of dedicated team for CMC writing as well as project management aspects for effective IND/IMPD writing (previous text here). This time we will focus on technical writing and preparation for it. Also, I will provide some primary recommendations for CMC writers.
The IND/IMPD being a regulatory document, has the same structure as CTD dossier. However, it includes remarkably less information on the developmental product, yet, the technical writers should understand that they will need to prepare the document in the way to reflect the actual production process and control further during the development in the later clinical phases.
Planning the CMC writing:
- Work with data developers closely. Be familiarized with the product and understand the background of product development.
- Know the anticipated changes during the development in advance. For the project manager, it is advisable to involve scientific/technical writers team into project discussions as early as possible.
- Identify reviewers. It can be functional leads or SMEs.
- If you are outsourcing CMC writing to specialized service providers, describe your strategy on product development and agree on data sharing process and review cycles.
- You will need to compile written documents electronically, creating an e-CTD application dossier. Take it into account when planning IND/IMPD. In case you do not have e-compiling capabilities in-house, consider an outsourcing partner as early as possible.
Preparation for CMC writing:
- There are two approaches to start writing – first, to wait for all generated documents, or, to begin writing sections once relevant documents are available along with the development. Both ways are good, though the choice depends on CMC writers resources, collaboration with the development team and IND/IMPD submission timelines.
- Determine what relevant documents you will need for authoring sections.
- Take data from QA, unless agreed otherwise. In such a case, you will have a guarantee that correct data are received with quality control (QC) already done.
- Keep at least two cycles of the review. It is a usual practice for finalization of the document.
- Hold Comments resolution meetings with all stakeholders, agree on each piece of information in order everyone is aware of the accepted changes and rationale behind it.
CMC writing – Keep it simple:
- Use a tailored template for your project. Remember that you need to prepare your template according to ICH guidelines in CTD format.
- If it is the first IND/IMPD you are working on and you have decided to do CMC writing with your internal resources, outsource the template from the experienced service provider.
- All descriptions in the IND/IMPD should be concise and precise.
- Use a simple technical writing style that regulatory agencies expect.
- Use a low level of granulation in the template, use bullet points.
- It is preferable to present data in tabular form complemented by brief narratives highlighting the main points. Do not rewrite the source documents.
- Identify any missing information during the authoring and keep preparing a list with your insights and recommendations to complement the document later during IND/IMPD updates.
- Check all authored sections for completeness, accuracy, consistency, correct structure and grammar.
Final note
The goal of CMC writing is to create a scientifically and editorially accurate high-quality document that can be submitted to regulatory authorities with a clear flow of information and required essential content reflecting the stage of product development. In this process, please consider regulatory reviewer work when authoring the document as well. For the reviewer, it will be easier to review the text when it is not only plainly written but also presented visually, clearly and in a structured way. And when the regulatory authorities have a smooth and clear document, your project runs smoothly as well.
If you want to get more information about CMC writing and outsourcing solutions, contact us!
Ramune Rukiene, MSc
Director Regulatory Affairs
Biomapas
