Regulatory Affairs
Utilize PPD’s proven expertise and comprehensive global services for
the most effective regulatory assessment and strategy for all stages of product
development. Our reputation for high quality submissions comes from our experience
helping our clients succeed.
Comprehensive Regulatory Services
With interdisciplinary teams and extensive internal resources, PPD's regulatory
affairs staff is flexible and responsive to your needs. Our regulatory consulting
services include:
- Scientific advice
- Orphan drug applications
- Competitive intelligence surveys
- Regulatory strategy definition
- Submission strategies
- Clinical trial applications, maintenance and trial support
- Pharmacovigilance processes
- Marketing applications
- Launch and post-approval activities
Product and Therapeutic Experience
PPD has developed regulatory strategies derived from novel scientific research,
biotechnology and advanced therapeutics for a wide array of products (new chemical
entities, biologicals, medical
devices). With a variety of therapeutic backgrounds,
our staff covers all major areas of research and development.
Global Expertise
PPD's strength lies in our global network and relationships with regulatory authorities.
With offices worldwide, we understand global regulatory requirements and submission
strategies, and act as a diplomatic and effective liaison with regulatory authorities.
Program Managers
Serving as client advocates within PPD, program managers bring a wealth of experience
and strong leadership skills to design and execute efficient development programs
for your products.
Chemistry, Manufacturing and Controls(CMC)/Toxicology
Consulting
PPD's global resources and expert staff help you create CMC/Tox programs that
are fully integrated with the clinical and regulatory plans of your drug development
program.
Strategy and Meetings
With expertise honed through the preparation of successful development plans,
PPD's experienced professionals assess strategies and risk, and facilitate or
participate in regulatory authority meetings.
Submissions
Experienced with regulatory agencies worldwide and with complex multinational
processes, PPD prepares all major regulatory submissions and provides extensive
quality control review.
Medical Writing
Our medical writing team develops clear, concise, and scientifically and medically
accurate documents that are fully compliant with regulatory requirements. We
assist with global clinical trial applications and other regulatory submissions,
as well as marketing application preparation.
Clinical Supply Management
PPD provides complete management of medical and pharmaceutical supplies through
ICH- and GMP-certified contract houses or PPD-owned distribution centers. For
European trials, PPD provides Qualified Person services and assists in the release
of investigational medicinal products.
