Helping Translate Life Sciences into Products
Recent and Upcoming Events:
Areas of Expertise
Since 2003, Kinexum has provided support to approximately 500 companies from around the globe developing cutting edge therapies for a range of diseases. With high unmet needs and growing healthcare costs, innovative and personalized approaches for the treatment of chronic diseases are of high value and interest. We have FDA consulting experience and expertise in most therapeutic areas, including but not limited to:
- Diabetes
- Endocrine
- Metabolic
- Cardiovascular
- Gastrointestinal
- Oncology
- Immunology
- Neurology
- Dermatology
- Ophthalmic
- Pain
- Wound Healing
- COVID-19
- Others
We have FDA regulatory consulting experience across a broad range of modalities, including:
- Small molecules
- Peptides
- Biologics
- Cell and gene therapy
- Devices, diagnostics, digital health
- Nutritional supplements
- Botanical products
- Others
Kinexum’s team includes over forty subject matter experts, most of which have MDs, PhDs, MBAs, or JDs, and are based across North America, Europe, and Asia. The cumulative decades worth of experience in regulatory agencies, industry, and/or academia translate into functional expertise in clinical trials, regulatory filings and practice, project management, clinical operations, non-clinical, CMC, medical writing, quality, compliance and audit, commercial strategy, corporate development, federal contracting and grants and innovation management.
Our Reviews
Why Kinexum?
There are various US FDA Consultants, from regulatory departments of multinational CROs to boutique firms to free-lance ex-FDA solo practitioners. Why choose Kinexum
Passion
We are development geeks, passionate about translation and development of life science products for unmet/under-met medical needs.
Extension of your management team
We are more than just external US FDA consultants – we advise you as if we are extensions of your management team, applying our subject matter expertise to help you achieve your organization’s goals.
Team Approach
We utilize a team approach to FDA Regulatory Consulting, assembling internal Subject Matter Experts (SMEs), and when needed, external SMEs from our network, to best represent the interests of clients and their projects.
Experience
Reputation
Client-Centric
Kinexum experts have in their prior lives hired and fired hundreds of consultants, so we know what turns on and turns off client management, boards and shareholders. We don’t up-sell or cross-sell; our obsession is what is in the best interests for the client and the project. We approach your projects as if it’s our company and our money.
Why Kinexum?
There are various regulatory consultants, from regulatory departments of multinational CROs to boutique firms to free-lance ex-FDA solo practitioners. Why choose Kinexum?
Passion
We are development geeks, passionate about translation and development of life science products for unmet/under-met medical needs.
Extension of your management team
We are more than just external consultants – we advise you as if we are extensions of your management team, applying our subject matter expertise to help you achieve your organization’s goals.
Team Approach
We utilize a team approach, assembling internal Subject Matter Experts (SMEs), and when needed, external SMEs from our network, to best represent the interests of clients and their projects.
Experience
Our consultants typically have decades of experience, with expertise and judgment, particularly about FDA expectations at the pre-clinical and clinical stages, across a broad set of therapeutic areas and modalities (including drugs, large molecules, advanced therapies and devices).
Reputation
While we are generalists, we also have a reputation as thought leaders in metabolic diseases (such as diabetes, obesity, NASH and endocrine diseases), and other chronic diseases of aging (including cardiovascular and neurodegenerative diseases and cancer), with a track record of pro bono activities, including our acclaimed Targeting Metabesity conferences.
Client-Centric
Kinexum experts have in their prior lives hired and fired hundreds of consultants, so we know what turns on and turns off client management, boards and shareholders. We don’t up-sell or cross-sell; our obsession is on what is in the best interests for the client and the project.