Combination product solutions
ELIQUENT Life Sciences brings clarity to regulatory complexity.
We are expert consultants delivering the solutions that combination product innovators need to gain and
maintain market authorization for their products. From thought to finish, concept to commerce, and strategy
to execution— ELIQUENT Life Sciences is the singular regulatory resource that clients around the world trust.
To approval and beyond.
As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. ELIQUENT’s
highly specialized combination product experts provide both strategic direction and technical support from
the earliest phases of development to post-approval regulatory support.
The ELIQUENT team has extensive experience with companion diagnostics, drug-coated devices, and a wide
range of drug delivery systems including subcutaneous, inhaled, injected, topical, intrathecal, and closed
loop. ELIQUENT’s comprehensive combination product solutions include:
Product
Classification
The ELIQUENT team
provides strategic and
technical guidance to
determine a product’s
regulatory identity
(classification) as
a drug, device,
biological product, or
combination product.
Premarket
Pathway
Guided by decades of
regulatory experience,
ELIQUENT experts
provide best-in-class
premarket support
across all potential
pathways, including:
NDA, ANDA, BLA, PMA,
510(k), De Novo.
Regulatory
Submission
ELIQUENT applies
extensive regulatory
perspective to
develop and
implement strategies
that optimize a
product’s regulatory
submission and
agency interactions
at every step.
Quality &
Manufacturing
ELIQUENT evaluates
and strengthens
systems with an eye
toward optimizing
processes, mitigating
risks, and creating a
culture of compliance,
while meeting business
objective.
Expert
Training
ELIQUENT’s
customizable training
programs equip
teams and employees
with the tools and
skills needed to
maintain regulatory
processes and build
a common culture of
accountability.
Unmatched expertise.
ELIQUENT’s team of respected professionals, along with a network of ready-to-deploy global experts,
possess the unmatched ability to solve the most technical challenges on a global scale. Our team
of combination product experts includes leaders – across medical devices, regulatory policy, and
manufacturing quality and compliance. Together, we unlock regulatory excellence.
Dan Schults, M.D.
Principal, Medical Device & Combo Products
Distinguished 35-year career includes service
as Director of the FDA’s Center for Devices and Radiological Health
Brian Burns
Partner
Extensive background in medical device quality and regulatory strategy, including leadership roles across the medical device industry.
Dan Schults, M.D.
Principal, Medical Device & Combo Products
One of the nation’s leading 510(k) experts, with an FDA career that spanned more than 30 years and included a pivotal role in developing the FDA’s 510(k) program.
Janet Whipple
Partner
More than 25 years of experience in medical device quality, regulatory compliance, design, and operations.
Mark Kramer
EVP, Medical Device & Combo Products
17-year FDA career included establishing and directing the Office of Combination Products and leading interdisciplinary review teams.
Brian Burns
EVP, Regulatory Compliance
15 years of experience on Capitol Hill, in the private sector, and at the FDA, including role as Deputy Chief of Staff
Full-Service Support
ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to provide a full- service engagement that delivers end-to-end support. No matter your pathway position, regulatory requirements, global market or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.
Regulatory Affairs Solutions
PV+ Postmarket Surveillance
Quality & Compliance
Remediation Solutions
Talent Solutions
From the earliest
phases of innovation
through regulatory
submissions, to post-
approval support,
ELIQUENT’s robust blend
of technical skill and
clinical expertise guide
companies to approval
and beyond.
With an approach
that includes both
strategic direction
and hands-on global
support, ELIQUENT’s
customized
pharmacovigilance
services empower
companies to operate
with confidence.
ELIQUENT’s team of
highly specialized
compliance experts
build customized
solutions that equip
companies with best-
in-class strategic
support, technical
expertise, and project-
based solutions.
Our team of respected
professionals and
global experts bring
an unmatched level
of credibility and trust
when interacting
with regulators and
guiding companies to
remediation solutions.
Whether you need a team of one or 100+, ELIQUENT’s talent solutions give you the ability to rapidly scale your team to the right size, with the right level of expertise, in the right locations.
ELIQUENT on LinkedIn
Unlock a wealth of knowledge from our team of experts who regularly share insights, analyses, and perspectives on industry trends, best practices, and emerging technologies.