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is a consulting company that advises investment firms, venture capital funds, and pharmaceutical, device, and biotechnology companies on a broad range of life sciences projects, medical products and technologies, R&D concepts and projects, regulatory issues, and commercial opportunities, both in the U.S. and abroad.
Our services cover the complete development process for drugs and devices -- from Discovery, Clinical Research, and Regulatory Approval through Pharmacovigilance, Pharmacoeconomics, and Therapeutic Outcomes.
WAI brings together a unique group of world-class scientists with expertise in a broad range of basic, medical, and pharmaceutical science and technology, as well as the regulatory process. We have in-depth knowledge and extensive experience in the pharmaceutical, biotech, and medical device industries and the FDA including :
- Drug discovery
- Translational research
- Drug development
- FDA and European regulatory agency processes
- Regulatory agency approval
We operate as an international network of firms and consultants based on our professional careers in the Pharma and Biotech industries, and (prior to industry) in Academic Medicine and Clinical Pharmacology.
offers the services you need, when and where they're needed: Strategic and Operational Services
in Product Development, Clinical Operations, Analysis / Planning, Due Diligence, Technical Assessment, and Business Development
For example, we will . . .
 Advise on Business Strategy
Provide Medical and Regulatory Due Diligence for company and product
acquisitions
Create a Product Development Plan
and implement a Development Program
customized to your product and
goals.
Write or independently review your NDA/BLA/PMA submission.
Add cutting-edge perspective,
plus wide-ranging current knowledge and
experience in drug and device discovery,
development, approval, and medical-
marketing.
Identify, organize and coordinate
the right experts who can help solve
your
problem
-- when and where they're needed,
keeping your projects on track
and
on time -- both in the US and abroad.
Provide interim management when the need arises.
Provide Expert Opinion for pharma, biotech and device litigation.
Create and deliver presentations and training related to
your scientific /
technological / therapeutic area.
Call on us for
STRATEGIC
SERVICES:
EXPERIENCE
AND VISION
Corporate Development Strategy
Advise on your company's Business Strategy
Perform Medical and Regulatory Due Diligence for Company or Product
acquisition
Product Development Strategy
from
Discovery through Marketing, including:
Evaluate the downstream relevance and importance of
Discovery
Technologies
Evaluate and
select Product Candidates & Development Portfolios
Write
Strategic Product Development Plans
Plan, write,
and carry out a Regulatory Strategy, including preparing
Preclinical,
Clinical, and Regulatory
Submission & Approval process
and documents
Preparation
for FDA meetings
Write or
independently review your NDA/BLA/PMA submission package
Product Support in the Market
Medical-Marketing
Benefit/Risk
Management
Pharmacovigilance and Corporate Safety Systems
Managing Adverse
Reaction Problems
Pharmacoeconomics
Therapeutic
Outcomes
Biomedical Innovation and Health Policy
Goverment and Industry
US and International
OPERATIONAL SERVICES:
EXPERTISE
TO HANDLE REAL-WORLD
DEVELOPMENT CHALLENGES
AND CREATE AN
INTEGRATED SOLUTION
Rapid
access to the right experts
through
a worldwide network of experienced professionals
in every area of
Drug and Device
Development
Evaluation and
selection of CROs, and supervision, if you
wish, from small,
single studies through large
NDA / BLA / PMA
programs
Clinical safety,
including Management of Adverse Reactions,
Product Liability,
and Corporate Drug
and Device Vigilance systems
Part-time or Temporary
Management (including startup)
of Medical,
Development, Safety and Regulatory
Departments
for companies that are
growing or restructuring,
or have special short-term needs
PRESENTATIONS / LECTURES
Topics
currently available for outside presentation or in-house training:
How to Increase Success Rates in Drug Development
Expedited and Accelerated Drug Development
Success Factors for Biotech and Emerging Companies
Drug Approval Standards: Today and Future
PharmacoGenomics
Outsourcing Development
Developing Botanicals to US NDA Standards
Developing Nutritional Supplements
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