Facet Life Sciences
Facet Life Sciences is a regulatory affairs and product development strategy partner for emerging biotech and science companies. They guide clients through FDA pathways for drug, biologic, and medical device development.
Facet Life Sciences specializes in guiding small life science companies through the complex journey of drug, biologic, and medical device development. They offer tailored solutions for every stage, from initial concept through commercialization, focusing on nimble, entrepreneurial approaches to navigate FDA's regulatory pathways with precision and expertise. Their services include acting as a US Agent, providing regulatory strategy and development guidance, gap analysis, medical writing for submission documents, meeting facilitation with the FDA, and regulatory submission leadership. Facet fosters collaborative relationships with the FDA (CDER, CBER, and CDRH) on behalf of their clients to progress products through development and secure market acceptance. With a team bringing decades of experience in product development, nonclinical, clinical, CMC, regulatory affairs, and commercial launch, Facet helps create and execute effective development plans and launch strategies. They are committed to aggressive, scientifically sound progress, aligning strategies with client resources and business objectives to translate science into product value and answers for investors or partners.
About
**Who they are**
Facet Life Sciences is a regulatory affairs and product development strategy partner for emerging biotech and science companies. They guide clients through FDA pathways for drug, biologic, and medical device development.
**Expertise & scope**
* Regulatory affairs and product development strategy
* Guidance through FDA pathways for drug, biologic, and medical device development
* US Agent services, communicating directly with the US FDA on behalf of sponsors
* Assistance for companies without a US presence requiring a US Agent to bring investigational or marketed products into the US
* Support for companies with a US presence needing contract US agent services due to limited in-house regulatory expertise or resources
* Fostering collaborative relationships with FDA (CDER, CBER, and CDRH)
* Preparation and conduct of successful meetings with the FDA
* Gap Analysis
* Strategic & Regulatory Development Guidance
* Medical Writing of Submission Documents
* Meeting with the FDA
* Regulatory Submission Leadership
* Strategic Statistical Services
**Reputation / proof points**
* Ken VanLuvanee, President/CEO, has over 25 years of pharmaceutical and technology expertise in the life sciences industry. He was previously the founder of Apyx, a life sciences regulatory consultancy acquired by Image Solutions (ISI), which was subsequently acquired by Computer Sciences Corporation (CSC).
* Ken VanLuvanee was a key participant in the development of the DIA EDM Reference Model, a cross-industry effort to apply standards to the organization and structure of R&D documentation.
Facet Life Sciences is a regulatory affairs and product development strategy partner for emerging biotech and science companies. They guide clients through FDA pathways for drug, biologic, and medical device development.
**Expertise & scope**
* Regulatory affairs and product development strategy
* Guidance through FDA pathways for drug, biologic, and medical device development
* US Agent services, communicating directly with the US FDA on behalf of sponsors
* Assistance for companies without a US presence requiring a US Agent to bring investigational or marketed products into the US
* Support for companies with a US presence needing contract US agent services due to limited in-house regulatory expertise or resources
* Fostering collaborative relationships with FDA (CDER, CBER, and CDRH)
* Preparation and conduct of successful meetings with the FDA
* Gap Analysis
* Strategic & Regulatory Development Guidance
* Medical Writing of Submission Documents
* Meeting with the FDA
* Regulatory Submission Leadership
* Strategic Statistical Services
**Reputation / proof points**
* Ken VanLuvanee, President/CEO, has over 25 years of pharmaceutical and technology expertise in the life sciences industry. He was previously the founder of Apyx, a life sciences regulatory consultancy acquired by Image Solutions (ISI), which was subsequently acquired by Computer Sciences Corporation (CSC).
* Ken VanLuvanee was a key participant in the development of the DIA EDM Reference Model, a cross-industry effort to apply standards to the organization and structure of R&D documentation.
Additional information
Facet Life Sciences serves as a critical liaison between sponsors and the US FDA, particularly for companies lacking a US presence. Their role as a US Agent involves direct communication with the FDA to facilitate the entry of investigational or marketed products into the United States. For established US entities, they offer contracted US Agent services when internal regulatory expertise or resources are insufficient. They emphasize fostering dynamic relationships with FDA centers (CDER, CBER, CDRH) to advance product development and assist clients in preparing for and conducting successful agency meetings. Their services are designed to expedite responses to regulatory inquiries and address FDA questions concerning client programs.
Key Highlights
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Facet Life Sciences acts as a US Agent, communicating directly with the US FDA on behalf of sponsors for investigational or marketed products.
Source
“As a US Agent, we communicate directly with the US FDA on behalf of a sponsor.”
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They guide emerging biotech and science companies through FDA pathways for drug, biologic, and medical device development.
Source
“They guide clients through FDA pathways for drug, biologic, and medical device development.”
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The company fosters collaborative relationships with FDA centers including CDER, CBER, and CDRH.
Source
“We foster collaborative, dynamic relationships with FDA (CDER, CBER, and CDRH) on your behalf to progress your product(s) through development.”
Certifications & Trust Signals
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Ken VanLuvanee, President/CEO, has over 25 years of experience in the pharmaceutical and technology sectors of the life sciences industry.
Source
“Ken VanLuvanee is a serial entrepreneur with over 25 years of pharmaceutical and technology expertise.”
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Ken VanLuvanee was instrumental in the development of the DIA EDM Reference Model for R&D documentation standards.
Source
“Mr. VanLuvanee was a key participant in the development of the DIA EDM Reference Model, a cross-industry effort to apply standards to the organization and structure of R&D documentation.”
Buyer Snapshot
Best for
- Emerging biotech and science companies
- Companies needing a US Agent for FDA interactions
- Organizations seeking regulatory strategy and product development guidance
How engagement typically works
- Direct communication with FDA on behalf of sponsors
- Collaborative relationship building with FDA centers
- Guidance through FDA pathways
Typical deliverables
- US Agent representation
- Regulatory strategy development
- FDA meeting preparation and conduct
- Gap analysis reports
- Submission document support
Good to know
- Best when requiring direct FDA communication for product entry into the US.
- Ideal for companies with limited in-house regulatory expertise or resources.
HQ:
Wayne, US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Product Type:
devices, drugs
Additional us_agent_fda Details
Product Types
drug, biologic, medical device
Registration Support
No
Recall Support
No
Inspection Support
No
Emergency Contact24x7
No
US Entity State
PA
Onboarding Steps
No
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