Strategy and Meetings

PPD’s experienced regulatory professionals assist with the development of regulatory strategies and are available to participate in regulatory authority meetings. With extensive expertise honed through the preparation of a vast array of successful development plans, our regulatory staff provides:

• Regulatory acumen
• Risk assessment
• Problem solving
• Responsiveness to changing demands
• Experience with numerous therapeutic areas and product types

Experienced Leadership

PPD provides management oversight for product authorization by regulatory agencies through:

• Facilitating the development of effective product labels
• Providing strategic development advice and targeted assistance
• Developing competitive intelligence surveys, including review and appraisal of the relevant regulatory environments and guidelines
• Defining and refining regulatory development plan content
• Preparing and maintaining high-quality documentation
• Representing or supporting interactions and negotiations with regulatory authorities

Global Reach and Understanding

With experienced regulatory professionals in North America, the European Union, Latin America and Asia, PPD is capable of serving as an experienced, diplomatic and effective liaison with all major global regulatory authorities. We also assist with the preparation of complex global regulatory development strategies.

Meetings Expertise and Support

Our services that support interactions and meetings with regulatory authorities include:

• Scientific, product development and regulatory advice
• Preparation of thorough briefing packages to achieve full potential of regulatory meetings
• Post-meeting analysis, response and dispute resolution
• Maintenance of archived files of all regulatory authority correspondence
• Training and coaching of your employees in these various activities

Submissions Expertise and Support

PPD prepares global regulatory submissions including all regulatory briefing packages. Our quality control procedures include review of documents for compliance with applicable guidelines. We also conduct critical appraisal and gap analysis of your submission and offer solutions early in the development process. Electronic submission services are available in addition to traditional paper document services.

Therapeutic Expertise:

PPD offers therapeutic expertise in the following areas:

• Anesthetic, critical care and scheduled/controlled drugs
• Anti-inflammatory, analgesic and ophthalmic
• Antiviral
• Biologics
• Biotechnology products
• Cardiorenal
• Dermatologic and dental
• Gastrointestinal and coagulation
• Gene therapy products
• Medical imaging, radiopharmaceutical
• Metabolic and endocrine
• Neuropharmacologic
• Oncologic
• Over-the-counter
• Pulmonary