We’re passionate about working with you to deliver the insight and business solutions you need so patients get the medicines they’re waiting for. To see how we can help you achieve your business goals, visit www.incresearch.com/consulting
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We’re passionate about working with you to deliver the insight and business solutions you need so patients get the medicines they’re waiting for.To see how we can help you achieve your business goals, visit www.incresearch.com/consulting
Biosimilars
CNS
Gastro & Hepatology
Endocrinology
Infectious Diseases
Ophthalmology Medical Devices Cardiovascular
Pediatrics
Respira
tory
W
omen
’s H
ealt
h Im
mun
olog
y In
f am
mat
ion
Oncology
Hematology
Trusted advisors delivering insightful solutions for healthcare
Development | Regulatory | Quality & Compliance | Pharmacovigilance | Market Development
Our Therapeutic Expertise
Our Consulting Experience
Market Development
Laying the foundations for a successful product launch
Regulatory
Strategic and timely regulatory consulting
to support efficient lifecycle management of
your products
Quality & Compliance
Pharmaceutical consulting and auditing to help you
identify and manage compliance risk
Pharmacovigilance
Implementing best practice PV services so
you meet drug safety and compliance guidelines
Development
Collaborating with you to create efficiencies
and enhance your organizational
productivity
We use an innovative consulting model, integrating core consulting skills and frameworks with genuine, in-depth functional and therapeutic expertise
What is our expertise?• Iterative clinical trial design• Regulatory agency meetings• Global regulatory strategy• Regulatory document preparation
and submission• Process definition and optimization• GxP auditing• Compliance advice• Value story development• Health system assessment• Franchise strategy development
Who are ?• We are a global advisory and
implementation support service for the biopharmaceutical industry
• Experienced senior team providing industry-relevant solutions
• 50+ consultants globally with offices in the US, UK and Japan
• Ongoing engagements with small biotechnology, mid-tier and top-tier pharmaceutical companies
Project Management Office leadership
IND/CTA and PIP preparation and submission
Selected Case Studies
Interactive interface for Quality Management System
NDA/MAA preparation and maintenance
Full-service provider of GxP, PV and Auditing Services
EU Clinical Trial Regulation Implementation Preparation
Aligned Phase III trial design with EU and US payer landscape
Pharmacovigilance Regulation Training
Playbook of tactics for biosimilar competition in EULifecycle
Phase IV
Phase III
Phase II
Phase I
For more informationabout INC Research’s consulting capabilities, please contact us at [email protected] or on one of the telephone numbers listed below:
United States Corporate Headquarters Raleigh, NC. Tel: +1 919 876 9300
United Kingdom Camberley, Surrey. Tel: +44 1276 481000
incresearch.com
Connect with
Jane Winter BSc. (Hons) F.I.C.R.Head of Global Consulting [email protected]
David Ewbank Market Development [email protected]
Keith Ruark, MBAMarket Development [email protected]
Robert WojciechowskiRegulatory [email protected]
Elaine B TaylorRegulatory [email protected]
Kim ArnoldQuality & Compliance [email protected]
Stephen Gunnigle, PhD, MBADevelopment [email protected]
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