Regulatory Affairs Capabilities
Our frequent interactions with regulatory authorities and our science-based approach expedites “Right First Time” submissions for a broad range of modern medicines.
Meet our Regulatory Affair Experts
Izi Bruker, PhD, MPH
SENIOR VP, CLINICAL, MEDICAL, AND REGULATORY AFFAIRS

Helpful Links
Here are some of our favorite resources on this topic
Markets That Benefit from Our Regulatory Affair Solutions
Combination Products
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics and Cell & Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.




The Kymanox Difference
At Kymanox we are more than consultants. We are partners with our clients and create custom solutions that meet each client’s unique needs.

"Right First Time” Execution
Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.

Proven Broad Expertise
Our team of experts is focused on life sciences with extensive experience across drug and device development. No matter your challenge, we can help you conquer it.

Flexibility & Agility
At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
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.
Read the Latest at Kymanox
Kymanox Announces First Fellow Position
New Position of Honor for Distinguished Kymanox Clinical and Regulatory, Affairs Lead
Thursday, 28 July 2022
Boston, Massachusetts and Morrisville, North Carolina, USA
Kymanox Corporation (“Kymanox”), a professional servic...
Analytical Techniques For Addressing Viral Vector Purification Challenges
When producing gene therapies, circular plasmids containing therapeutic DNA , an outer capsid shell, and proteins required for virus assembly are inserted into host cells. Manufacturers often face difficulties creating consistency in gene therapy produ...
Rapid Microbiologic Methods Aid In The “Race To Release” Challenges Of Cell And Gene Therapy Manufacturing
Rapid Microbiologic Methods (RMM) is perfectly suited to cell-based manufacturing because it allows scientists to obtain results up to ten times faster than traditional culture-based microbiological analysis techniques and with less produ...