Our comprehensive Regulatory Services are tailored to navigate the complexities of pharmaceutical compliance across global markets. From dossier preparation and submission to regulatory strategy development, we ensure your product meets the highest standards of compliance. Our expertise includes:
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Preparation and Review of Drug Products / Semi-Finished Products/ Drug Substance
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eCTD/CTD/ ACTD/Regional: Dossier/ Drug Master File (DMF) preparation and compilation
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Post Submission Support Variation/ Handling of Queries