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 that guides emerging biotech and science companies through FDA pathways for drug, biologic, and medical device development. They focus on transforming how small organizations bring innovative products to market.
**Expertise & scope**
* Regulatory affairs and product development strategy
* Guidance through FDA pathways for drugs, biologics, and medical devices
* US Agent services, communicating directly with the US FDA on behalf of sponsors
* Assisting companies without a US presence to bring investigational or marketed products into the US
* Providing contract US agent services for companies with a US presence needing regulatory expertise or limited resources
* Developing efficient product development strategies and executing tactical plans
* Expertise spanning the entire development lifecycle
* Regulatory submission leadership
* Medical writing of submission documents
* Strategic statistical services
* Gap analysis
**Reputation / proof points**
* Founded by Ken VanLuvanee, President/CEO, with over 25 years of pharmaceutical and technology expertise in the life sciences industry.
* Previous experience includes founding a life sciences regulatory consultancy acquired by Image Solutions (ISI), which was later acquired by Computer Sciences Corporation (CSC).
* Experience in leadership roles responsible for strategic and operational performance.
* Involved in the development of the DIA EDM Reference Model for R&D documentation standards.
Facet Life Sciences is a regulatory affairs and product development strategy partner that guides emerging biotech and science companies through FDA pathways for drug, biologic, and medical device development. They focus on transforming how small organizations bring innovative products to market.
**Expertise & scope**
* Regulatory affairs and product development strategy
* Guidance through FDA pathways for drugs, biologics, and medical devices
* US Agent services, communicating directly with the US FDA on behalf of sponsors
* Assisting companies without a US presence to bring investigational or marketed products into the US
* Providing contract US agent services for companies with a US presence needing regulatory expertise or limited resources
* Developing efficient product development strategies and executing tactical plans
* Expertise spanning the entire development lifecycle
* Regulatory submission leadership
* Medical writing of submission documents
* Strategic statistical services
* Gap analysis
**Reputation / proof points**
* Founded by Ken VanLuvanee, President/CEO, with over 25 years of pharmaceutical and technology expertise in the life sciences industry.
* Previous experience includes founding a life sciences regulatory consultancy acquired by Image Solutions (ISI), which was later acquired by Computer Sciences Corporation (CSC).
* Experience in leadership roles responsible for strategic and operational performance.
* Involved in the development of the DIA EDM Reference Model for R&D documentation standards.
Additional information
Facet Life Sciences serves as a US Agent, acting as the direct point of contact with the US FDA for sponsors. This role is crucial for companies lacking a US presence, as a US Agent is mandatory for importing investigational or marketed products. For companies already in the US, engaging a contract US agent is beneficial when in-house regulatory expertise is limited or resources are stretched. Facet Life Sciences emphasizes fostering collaborative relationships with FDA centers (CDER, CBER, CDRH) to advance client products through development. They utilize secure communication channels to quickly address regulatory questions and assist clients in preparing for and conducting successful meetings with the agency.
Key Highlights
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Facet Life Sciences guides clients 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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Acts as a US Agent, communicating directly with the US FDA on behalf of sponsors.
Source
“As a US Agent, we communicate directly with the US FDA on behalf of a sponsor.”
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Founded by Ken VanLuvanee, who has over 25 years of pharmaceutical and technology expertise in life sciences.
Source
“Ken VanLuvanee is a serial entrepreneur with over 25 years of pharmaceutical and technology expertise.”
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The company's founder previously established a life sciences regulatory consultancy that was acquired.
Source
“Mr. VanLuvanee was the founder of Apyx, a life sciences regulatory consultancy which was acquired by Image Solutions (ISI)”
Certifications & Trust Signals
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The company's founder was instrumental in implementing the DIA EDM Reference Model for R&D documentation.
Source
“He was instrumental in both executing on the vision of the reference model and assisting sponsors in the implementation of the model”
Buyer Snapshot
Best for
- Emerging biotech and science companies
- Companies seeking FDA regulatory pathway guidance
- Organizations needing a US Agent for FDA interactions
How engagement typically works
- Collaborative partnership
- Direct FDA communication
- Strategic development planning
Typical deliverables
- FDA pathway strategy
- US Agent representation
- Regulatory submission documents
- Meeting preparation with FDA
- Product development strategy
Good to know
- Best when requiring specialized regulatory expertise for FDA submissions and interactions.
HQ:
Wayne, US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Product Type:
devices, drugs
Annual Renewal Support:
Yes
Registration Support:
Yes
Recall Support:
No
Inspection Support:
No
Emergency Contact24x7:
No
Annual Renewal Reminder:
Yes
Additional us_agent_fda Details
Product Types
Drugs, biologics, medical devices
Registration Support
Implied through US Agent services and FDA interaction
Recall Support
No
Inspection Support
No
Emergency Contact24x7
Implied through direct communication capabilities
US Entity State
PA (based on address provided)
Onboarding Steps
Implied through the need to understand client science and product development strategy
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