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Regulatory CMC Services

  • Authoring & Submission of new ANDA-DMFs

  • Management of review deficiencies

  • Review and management of variations

Regulatory Labeling 

  • Monitoring of brand label changes

  • Creation of generic package insert or SmPC

  • Management of artworks 

  • Submission of variations

Regulatory clinical/non-clinical reports

  • Literature survey for NCO/CO

  • Authoring and review of Non-clinical and clinical overviews​

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> Schedule your appointment online

Unireg Pharmaceutical Regulatory Consultancy Services

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