Regulatory Affairs Advisory Services

Kymanox® provides support for regulatory strategy and development planning by emphasizing a patient-centric, risk-based approach that supports the introduction and ongoing support of a variety of products including first-in-class products and their unique challenges.
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Regulatory Pathway Analysis

Our regulatory experts have vast experience with uniquely challenging drugs, medical devices, biologics, and combination products. Our team can analyze potential registration pathways for your early-stage products that fit your business needs and desired commercial market. This analysis includes applicable regulations and standards, as well as development requirements to enable clinical investigations.
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Regulatory Gap Assessments 

Our regulatory experts have experience achieving commercial and clinical success with Regulatory applications. Our team can perform gap assessments of the eCTD sections of your New Dug Application (NDA), Biologic License Application (BLA), and Investigational New Drug Application (IND) to identify the presence and severity of regulatory risks with respect to Refuse to File (RTF) or approval potential.
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Post-Market and Lifecycle Management

Kymanox can assist with vigilance, safety reporting/annual updates, complaint investigations, and lifecycle management activities. Our team can also help assess and identify new indications for existing drugs or new dosage forms/route of administration.
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