OUR ACTIVITIES

Medicines Regulatory Consultancies

Medical Supplies and Consultancy Services

Pharmaceutical Supplies and Consultancy Services
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New Product Authorisations
Presubmission technical data reviews | Gap Analysis | Regulatory Content authoring | Dossier compilation, validation and final submission of new product authorization applications for global filing | Review Gap Analysis & Remediation Advisory | Dossier Authoring - CMC Sections & Summaries | Biowaiver Justifications | SmPC/PIL/PI authoring/Reviews | Agency Query responses
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