Do you have all your data but no one to put it in writing in time for submission? A medical writer may be just what you need! Give us call.
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CTD (Common Technical Document) describes the organisation of the regulatory documents supporting the authorisation of medicinal products.
The eCTD (electronic CTD) is a harmonised technical solution to implementing the CTD electronically. It consists of PDF documents, arranged in a set structure with defined folder and document names. eCTD is to be used when submitting documentation to authorities.
eCTD requires a dedicated software that creates separate Table of Contents with hyperlinks to the included documents, XML backbones and hyperlinks between documents.
Need help with eCTD publishing? Give us a call.
Did you know that RegFile is part of the brilliant consultancy group Center for Translational Research?
Last week the CTR siblings met in Sigtuna, to discuss how to develop our complementary services and collaboration to support our clients even better. Current business trends were also on the agenda to make sure we stay on top of things!
CTR consists of RegSmart, Clinical Trial Consultants (CTC), Toxicology Knowledge Team (TKT), MetaSafe, Lablytica and RegFile.
The Clinical Overview is one of the most important documents on your way to Marketing Authorisation. It is an in-depth critical analysis of your complete drug development programme and its results, including discussion and interpretation of clinical findings.
The overview presents the strengths and limitations of your programme and study results and analyse clinical benefits and risks. It describes how study results support the critical parts of the prescribing information, such as indication, dosage, safety profile and more.
A clinical overview is needed also for generic- and hybrid applications but in these cases the key messages could generally be based on the reference product.
Need help writing a clinical overview? Give us a call.
5 tips
1. Make sure a Change Control (CC) case is opened and that a project is set up, together with relevant co-workers. This is important, also for smaller changes.
2. Correct classification is key. Study the classification guideline carefully and ask a colleague for advice if you feel unsure. For non-standard variations, always confirm the classification with the agency.
3. Go through your dossier, what documentation is affected by the change? Also consider documents outside module 3, such as the product information.
4. Compile the variation package as required for your variation type and ask a colleague to review it with ”fresh” eyes before submitting to the agency.
5. Be clear about agency timelines, when communicating with the manufacturer. This will facilitate well-planned and correct implementation of the change.
Seem complicated? Contact us. At RegFile we have extensive experience in CMC variations and extensions, both from industry and competent authorities.
*Regulatory changes concerning Chemistry, Manufacturing and Control
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Eklundshovsvägen 1G, 752 37 Uppsala, Sweden
info@regfile.se
