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.
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Navigating the Regulatory Landscape

Kymanox® is experienced in the interpretation of applicable FDA and EMA regulations to ensure compliance, and we support efficient navigation through the multidimensional regulatory landscape.
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02

Extensive Expertise 

Support for regulatory strategy and development planning, regulatory submissions and agency questions, cGxP compliance, and pre-approval inspection (PAI) readiness.
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03

First-in-Class Product Support

We emphasize 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

We can perform a regulatory pathway analysis for drugs, devices, biologics, or combination products. We can identify relevant guidances or requirements relevant to the product, assess the appropriate approval pathway. We perform these assessments for the US or other countries as requested and author our findings in a presentation or report.
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Orphan Drug Designation (ODD) Requests

We have helped many clients with their Orphan Drug Designation (ODD) requests. First, we conduct an assessment of disease prevalence and existing ODD indications for an Active Pharmaceutical Ingredient (API) to confirm eligibility. We then prepare the ODD request per FDA requirements and submit if requested.
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FDA Expedited Program Request

Kymanox can author or review your FDA expedited program request including Fast Track Requests (FTRs), Breakthrough Therapy Requests (BTRs), Accelerated Approval (AA) assessments or requests, and Priority Review (PR) assessment or requests. We will ensure these documents follow FDA guidelines and applicable standards.
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Gap Assessments

Our regulatory experts have experience performing gap assessments of our clients' clinical strategies or clinical endpoints including the overall clinical program, synopsis of a clinical study, or identification of primary endpoints. We can also perform a gap assessment of the eCTD sections of your New Dug Application (NDA) or Biologic License Application (BLA) and identify potential regulatory risks and level of risk with respect to Refuse to File (RTF) or potential for approval. We can also perform a regulatory assessment of the device class, product code, predicate assessment (if applicable) to determine the appropriate pathway for commercialization in the US or other countries as specified; identify any special controls or relevant guidance. Our team can also help assess and identify new indications for existing drugs or new dosage forms/route of administration.
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08

Pediatric Study Plans

Our regulatory team has experience authoring initial Pediatric Study Plans (iPSPs) and addressing FDA comments to a "non-agreement" iPSP. We can also participate in FDA meetings to negotiate requirements as applicable.
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Meet our Regulatory Affairs Experts

Izi Bruker, PhD, MPH
FELLOW, CLINICAL, MEDICAL, AND REGULATORY AFFAIRS

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 & Cell and Gene Therapy Services

We understand why “the product is the process” and how to implement solutions to your unique challenges.

Pharmaceuticals

Drug development is constantly evolving with new regulations and technology. We stay up to date to maintain your compliance.

Medical Devices & Other

Our diverse experience across the life science industry, including medical device and vaccines, ensures your challenges are in expert hands.

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.
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"Right First Time” Execution

Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.
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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.
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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.
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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.