DDReg Pharma

Publishing Services

Our robust infrastructure and management processes ensure that Dossier conversion. eCTD management and paper submissions are conducted efficiently and adhere to different country guidelines.

Paper Submission

Some of the regulatory Agencies require submission of dossiers and regulatory documentation in...

Dossier Conversions

A lot goes behind developing a market specific dossier for submission. An applicant ...for such product would

eCTD Conversion & Submission

Improve and optimize your electronic submission management and processes. We help create and...

While some regions accept paper dossier submissions, the eCTD format has been declared mandatory by many regulatory authorities worldwide. Thus, the need to convert paper INDs, NDAs and DMFs to the eCTD format is imperative. Marketing authorization applications must be technically compliant with respect to submitted documents. To ensure appropriate assessment of the regulatory procedures, the baseline sequence must be submitted. This should include the compiled dossier in the eCTD or as a NeeS. Technical assessment of the eCTD against ICH specifications is a requirement to ensure validation before it can be submitted.

DDReg ensures appropriate conversion of dossiers, while adhering to guidelines and specifications. DDReg uses fully validated eCTD tools that are 21CFR part 11 compliant.

DDReg’s publishing services include:
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