Helping you Translate Life Sciences into Products

Translating scientific discoveries into healthcare products is our passion! Kinexum provides strategic and operational guidance and execution on regulatory, clinical, CMC, and related development challenges throughout the product development process and into commercialization.

Areas of Expertise

Kinexum Executive Chairman Alexander Fleming, MD moderating a panel at Diabetes Technology Meeting

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 experience and expertise in most therapeutic areas, including but not limited to:

  • Diabetes
  • Endocrine
  • Metabolic
  • Cardiovascular
  • Gastrointestinal
  • Oncology
  • Immunology
  • Neurology
  • Dermatology
  • Opthalmic
  • Pain
  • Wound Healing
  • COVID-19
  • Others

We have 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.

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.

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.

Services

Corporate and Program Strategy

Corporate and Program Strategy

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Regulatory Strategy and Operations

Regulatory Strategy and Operations

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Chemistry Manufacturing and Controls

Chemistry Manufacturing and Controls

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Clinical Strategy and Operations

Clinical Strategy and Operations

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Quality, Compliance and Audit

Quality, Compliance and Audit

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Due Diligence, Assessments and Rescue

Due Diligence, Assessments and Rescue

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Federal Grants and Contracts

Federal Grants and Contracts

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