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 |
Franz Josef Buchholzer, M.Sc, PhD Vice President, Regulatory Operations Worldwide Dr. Buchholzer has more than 20 years of experience with international pharmaceutical companies at the corporate management level and has been extensively involved with clinical trial applications and worldwide regulatory dossier submissions. Multilingual, he has provided strategic regulatory assistance for drug development programs and/or stand-alone services, and his regulatory portfolio includes biotech products, NCEs and other innovative products covering the following indications: anaemia, heart failure, oncology, neurology, immunology, dermatology, growth, fertility and respiratory. Dr. Buchholzer has worked internationally with colleagues from various regulatory agencies and has been a speaker at several prominent congresses. He is a pharmacist and holds a PhD in pharmaceutical sciences from the University of Geneva in Switzerland. |
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. |
Ping Xu, B.Sc, MBA Associate Director, Regulatory Operations Ms. Xu has had extensive interactions with regulatory agencies such as the State Food & Drug Administration (SFDA), Ministry of Health of the People’s Republic of China (MOH), Center for Drug Evaluation (CDE), National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) and Center of Medical Device Evaluation (CMDE) during her more than 14 years of experience in the pharmaceutical and CRO industries. She has developed regulatory submission strategies and is experienced in the preparation of submission dossiers and clinical/marketing license applications. Additionally, Ms. Xu has managed all aspects of clinical trial operations, including site selection, contract and relationship maintenance and site monitoring, data management and medical writing under Chinese GCP and related regulations. |
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