Regulatory Affairs Assessment and Strategies
PPD provides the most effective regulatory assessment and strategy for all stages of pharmaceutical, biologic and medical device product development and life cycle management. Our reputation for high-quality regulatory submissions comes from our experience helping our clients succeed.
Comprehensive Regulatory Affairs 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:
- Regulatory strategic consulting
- Regulatory submission consulting
- Clinical trial authorizations, maintenance and trial support
- Orphan drug and humanitarian device applications
- Competitive and regulatory intelligence
- Regulatory authority meeting preparation and facilitation
- 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 Regulatory 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.
Regulatory 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. They can help speed your product through the approval process.
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.
