A-pharmaconsult Medical and Non-clinical writing

The Common Technical Document (CTD) provides a common framework for drug registration that is shared between North America, Europe, and Japan.

CTD documentation must comply with guidelines defined by the International Council on Harmonization (ICH) and is therefore highly technical, demanding expertise and specialist writing skills that A-pharmaconsult can provide.

CTD Modules

A-pharmaconsult can provide specific support in writing each of the five main Modules involved in a CTD submission. Pharma companies often require expert asssistance with:

• Module 2: Overviews and summaries including Module 2.4 (Nonclinical overview), Module 2.5 (Clinical overview), Module 2.6 (nonclinical written and tabulated summaries), and Module 2.7 (Clinical summary of pharmacology studies, efficacy, safety, literature references, and study synopses)
• Module 3: Quality
• Module 4: Safety
• Module 5: Efficacy

A-pharmaconsult Medical and Non-clinical support

A-pharmaconsult expertise in Regulatory Affairs for drugs encompasses all Modules of the Marketing Authorization (MA) Dossier.

Relevant aspects of A-pharmaconsult knowledge and experience include product positioning and regulatory strategy, literature searches, documentation review, the non-clinical overviews, summaries & Expert Statement involved in CTD Modules 2.4, 2.6 & 4, and the clinical overviews, summaries and Expert Statement required for CTD Modules 2.5, 2.7, and Module 5.

A-pharmaconsult can also identify the relevant Expert qualified to provide review and signature.

CTD Conversion and submission

A-pharmaconsult can also provide the technical support required to convert the completed CTD into eCTD form for electronic submission.

This support can assist our clients with bibliographical research, analysis of documentation, along with the clinical writing, non-clinical writing, and medical writing skills and experience required to complete the document in fully compliant form and ensure successful submission of dossier to the health authorities in due time to meet regulatory deadlines.

These CTD writing services can also be applied to product variation applications, including gap analysis, to ensure that client organizations have fully compliant documents ready to submit well before regulatory deadline.

Resources

Click on A-pharmaconsult Regulatory Affairs Services  for further information.