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.

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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Frequently Asked Regulatory Affair Questions (FAQs)

Does the FDA approve cosmetics before they go on market?
Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives (other than those intended for use as coal-tar hair dyes). FDA's authority over cosmetics is post-market. FDA may take regulatory action if it has information to support that a cosmetic is adulterated or misbranded. The agency can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market. 
What is the definition of General Wellness Product?
A general wellness product has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition. 
What is Software as a Medical Device?
Software as a Medical Device (SaMD) is often described as “software intended to be used for one or more medical purposes without being part of a hardware medical device."  Use of SaMD is continuing to increase.  It can be used across a broad range of technology platforms, including medical device platforms, commercial "off-the-shelf" platforms, and virtual networks, to name a few. Such software was previously referred to by industry, international regulators, and health care providers as "standalone software," "medical device software," and/or "health software." 
With which regulatory filings can Kymanox assist?
Kymanox interacts on behalf of our clients with regulatory bodies and health authorities to lead various filing activities (e.g., IDE, PMA, IND, NDA, BLA) and to lead negotiations that resolve issues and respond effectively to 483s, Warning Letters, Consent Decrees, and Complete Response Letters.