The PharmaNet Regulatory Affairs team has the experience to anticipate the challenges of product development and the expertise to help resolve issues. With broad experience working in regulatory agencies, PharmaNet's seasoned professionals bring strategic insight to the product development process. PharmaNet offers a comprehensive range of Regulatory Affairs services, including:
Worldwide Regulatory Services
 Regulatory strategy and clinical development planning |
| Preparation and submission of regulatory documents |
| Facilitation of relationships with regulatory authorities worldwide |
| Quality assurance and regulatory compliance |
| Medical writing |
Electronic Submission Services
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Regulatory submissions with state-of-the-art software tools (e.g., Documentum®, CoreDossier®) |
| Automation of quality-control procedures |
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| Facilitation of review process |
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Consulting Services
| Strategic Planning |
| Regulatory strategy for product development |
| Objective advice on advertising and promotion |
| Review of products and portfolios |
| Analysis of in-licensing candidates |
| Evaluation of internal processes |
| And many other services through PharmaNet Consulting |
Gregory M. Hockel, MBA, PhD Senior Vice President, Regulatory Affairs Worldwide Dr. Hockel has more than 20 years of pharmaceutical, biotechnology, and CRO industry experience, including more than 15 years in regulatory affairs. Throughout his career, Dr. Hockel has been extensively involved in planning, compiling, and submission of numerous NDAs/BLAs and INDs. Additionally, he has led initiatives involving drug safety, GCP auditing, compliance, and clinical-trial supply management. |
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