CTD Quality Consulting offers the following
consulting services:
- Preparation of clinical and marketing applications (IND, IMPD, NDA, ANDA, BLA, MAA) for drugs, biologics, and combination (drug-device) products in CTD and eCTD format. We guide your authors and/or provide writing services.
- Preparation of the Quality Overall Summary.
- Detailed eCTD Templates with
content and format for INDs, NDAs, and BLAs from ICH and regional guidelines,
with customized content and granularity for your products and preparation
of submission ready documents. Click HERE for more information.
- Conversion of current submissions to CTD or eCTD with appropriate level of granularity.
- Preparation of eCTD (electronic submissions) documents in collaboration with eCTD vendors.
- Technical and regulatory review of regulatory submission documents and drug
master files (DMFs)
- Gap analysis, including mapping
of source documents to the CTD
- Medical Writing – preparation of clinical study reports and other nonclinical and clinical documentation and CTD summaries.
- Submission Process Optimization and Regulatory Training (SPORT); guides clients in efficient workflow and submission processes.
- Preparation of FDA meetings and pre-meeting packages.
- Due diligence review of CMC documents for licensing.
- SOPs and Quality Manuals, GMP auditing.
- Technology Transfer Documents
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CTD Quality Consulting recommends that you begin preparation
of your CTDs early in drug development, at the IND stage. All documents
should be planned for the end goal of marketing your drug product.
Consider transitioning to the electronic CTD (eCTD)
ASAP for potentially very significant advantages in:
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FDA review and approval of marketing applications, and...
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Life cycle management starting with early phase IND.
We can help you author eCTD documents before your company is ready
to file eCTD, to prepare you for a rapid transition as soon as
your electronic publishing system is in place.
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