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 for investigational or marketed products entering the US.
* Assistance for companies with or without a US presence requiring regulatory expertise or limited resources.
* Fostering collaborative relationships with FDA (CDER, CBER, and CDRH) to progress products through development.
* Facilitating quick answers to regulatory questions and assisting clients in preparing for and conducting successful meetings with the agency.
* 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, previously founding Apyx, a life sciences regulatory consultancy acquired by Image Solutions (ISI), then Computer Sciences Corporation (CSC).
* Ken VanLuvanee was a key participant in the development of the DIA EDM Reference Model.
* The company is headquartered in the Midwest.
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 for investigational or marketed products entering the US.
* Assistance for companies with or without a US presence requiring regulatory expertise or limited resources.
* Fostering collaborative relationships with FDA (CDER, CBER, and CDRH) to progress products through development.
* Facilitating quick answers to regulatory questions and assisting clients in preparing for and conducting successful meetings with the agency.
* 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, previously founding Apyx, a life sciences regulatory consultancy acquired by Image Solutions (ISI), then Computer Sciences Corporation (CSC).
* Ken VanLuvanee was a key participant in the development of the DIA EDM Reference Model.
* The company is headquartered in the Midwest.
Additional information
Facet Life Sciences serves as a US Agent, a critical role for companies looking to bring investigational or marketed products into the United States, especially those without a US presence. For companies with an existing US footprint, engaging a contract US agent is beneficial when in-house regulatory expertise is lacking or resources are constrained. The firm emphasizes understanding the sponsor's science and leveraging a deep history of FDA interaction to foster dynamic relationships with the agency across CDER, CBER, and CDRH. They utilize secure communication channels to expedite responses to regulatory inquiries and assist clients in preparing for and conducting successful agency meetings, interacting with the FDA on a daily basis on behalf of their clients.
Key Highlights
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Provides US Agent services, 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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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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Fosters collaborative relationships with FDA (CDER, CBER, and CDRH) to progress products through development.
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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President/CEO Ken VanLuvanee has over 25 years of pharmaceutical and technology expertise.
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 executing and assisting sponsors with the implementation of the DIA EDM Reference Model.
Source
“He was instrumental in both executing on the vision of the reference model and assisting sponsors in the implementation of the model within their technology landscape.”
Buyer Snapshot
Best for
- Emerging biotech and science companies
- Companies needing FDA regulatory guidance
- Companies without a US presence requiring a US Agent
How engagement typically works
- Direct communication with FDA on behalf of sponsor
- Collaborative relationship building with FDA
- Guidance on FDA pathways
Typical deliverables
- US Agent services
- Regulatory strategy development
- FDA meeting preparation and conduct
- Submission document support
- Gap analysis
Good to know
- Best when seeking expert FDA liaison and regulatory strategy support.
HQ:
Wayne, US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Product Type:
devices
Additional us_agent_fda Details
Product Types
drug, biologic, and medical device
Registration Support
No
Recall Support
No
Inspection Support
No
Emergency Contact24x7
No
US Entity State
PA
Onboarding Steps
No
