Authoring, Publishing and Submissions
Building applications that are comprehensive and fully prepared for timely Agency approval
Authoring, Publishing and Submissions
Building applications that are comprehensive and fully prepared for timely Agency approval
Authoring and delivering outstanding regulatory submissions
We ensure that all regulatory documents meet the highest standards of compliance, accuracy and clarity, facilitating timely approvals and effective communication with regulatory authorities worldwide.
Submission authoring
Our team specializes in the authoring of all regulatory submissions and special designations, ensuring that your dossiers are comprehensive, compliant, and prepared for Agency review and approval.
Services include:
- Modules 1–5 eCTD authoring/review/supporting documents
- CMC authoring
- Medical writing
- All submission types - IND, CTA, IMPD, NDA, BLA, MAA and ROW submissions
- Pediatric plans (PSP/PIP), orphan designations, and other special designations
- DMF preparation
eCTD publishing and filing
G&L provides end-to-end publishing services, managing every aspect of submission builds and management across all regions.
Services include:
- Submission build/eCTD backbone development
- Electronic publishing (eCTD/Nees) and validation
- Submission management
- Portal submission and archiving
Regulatory submissions
We meticulously compile, review, and manage all necessary documentation for your submissions, ensuring compliance with global regulatory requirements.
Services include:
- NDA/BLA [505(b)(1) & 505(b)(2)]
- EU MAAs
- ANDAs and generic applications
- INDs/CTAs
- ROW submissions
- EU National Phase submissions
Experience you can trust
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30k
CTD sections authored
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10k
Variations, supplements and amendments
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250+
New market rollouts
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