Pharma Regulatory Excellence
Our pharmaceutical services cover the entire product lifecycle. Whether you are developing a new chemical entity, a generic, or a biologic, our team ensures your regulatory strategy is robust, compliant, and optimized for speed to market.
CMC Technical Writing
High-quality Chemistry, Manufacturing, and Controls documentation for Module 3.
Learn moreDossier Authoring Services
Comprehensive authoring of CTD/eCTD modules for NDA, ANDA, and MAA submissions.
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Technical compilation, validation, and publishing of electronic submissions.
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Identifying critical gaps in your regulatory strategy or documentation.
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Ensuring packaging and PILs meet regional regulatory standards including FDA and EMA.
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Managing post-approval variations, renewals, and annual reports.
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Tailored strategies for entering emerging and established pharmaceutical markets.
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Clinical Study Reports (CSRs), Protocols, and Investigator Brochures (IBs).
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Expert advisory for complex regulatory pathways and agency interactions.
Learn moreRegulatory Intelligence Services
Keeping you ahead of the curve with latest guideline updates and policy changes.
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