CTD / ACTD Dossier Preparation
ERA (Excellence in Regulatory Affairs) provides
professional CTD (Common Technical Document) and
ACTD (ASEAN Common Technical Document) dossier
preparation services for pharmaceutical companies
seeking product registration in domestic and
international markets. Our experts ensure that
dossiers are structured, compliant and submission-ready
according to regulatory authority requirements.
We assist organizations in compiling high-quality
regulatory dossiers for finished pharmaceutical
formulations including Tablets, Capsules, Syrups,
Dry Syrups, Ointments, Creams, Injections,
Parenterals and other dosage forms. Our systematic
approach helps minimize regulatory deficiencies and
supports faster product approvals.
Our CTD / ACTD Services Include:
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CTD Dossier Preparation –
Preparation and compilation of Common
Technical Documents in accordance with
ICH guidelines and regulatory requirements.
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ACTD Dossier Preparation –
Preparation of ASEAN Common Technical
Documents for product registrations in
ASEAN member countries.
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Country-Specific Dossiers –
Development of customized dossiers based
on individual country registration
requirements and regulatory guidelines.
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Module Compilation & Review –
Preparation and review of Administrative,
Quality, Non-Clinical and Clinical modules.
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Gap Analysis & Documentation Review –
Identification of deficiencies and
compliance gaps before submission.
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Regulatory Query Response –
Support for responding to authority
questions, deficiency letters and
post-submission observations.
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Lifecycle Management Support –
Assistance with renewals, variations,
amendments and post-approval maintenance.