RegAgile

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Our Solutions

RegAgile helps you create and implement integrated development and commercial plans to deliver your innovation to patients.

Rx to OTC Switch

Rx to OTC switch Landscape
Feasibility assessment
Gap analysis

Regulatory Strategy development

Regulatory advice to advance product development
Strategic approach
Empower innovative regulatory strategies to support faster market access
Regulatory compliance check

Regulatory Environment monitoring & Health Authority consultation

Articulate client’s position and questions on regulatory issues, preparing required documents, organizing meeting and presenting to authorities
Regulatory meetings - sponsor representative & health authority liaison

Claims design, selection, substantiation and labeling

Scientific Evaluation of Claims
Evaluate Clinical and real-world evidence (safety & Efficacy)
Claims supported by Market research (expert endorsement, perception claims, sensory claims etc.)
Functional / Health / Nutritional claims
Regional / global / local Label review

Regulatory Assessment

Review the technical and clinical data
Assess Legal Basis / Product classification
Due diligence and Gap Analysis
Dossier review
Product review for submission strategy

Ingredient Assessment

Evaluate ingredients and their levels (GRAS, EFSA and local approval status)
New Combination products review
Safety & Efficacy substantiation assessment

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