Document Preparation and Review:
Dr. Wolfe assists clients in the preparation and review of regulatory documents (IND, NDA, SPA, and IB), manuscripts, study reports, SOPs, MSDSs, and position papers. His expertise assures clients that these submissions are consistent and meet regulatory requirements.
Regulatory Documents – Dr. Wolfe is experienced in formatting published findings in a manner consistent with the FDA submission process. Specifically, Dr. Wolfe has extensive experience in the preparation and submission of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Special Protocol Assessments (SPAs), and Investigational Brochures (IBs).
Manuscripts – For clients that would like to publish study results in the open scientific literature, Dr. Wolfe is able to prepare manuscripts for submission to peer reviewed scientific journals.
Study Reports – Dr. Wolfe is able to provide comprehensive GLP-compliant report preparation services using data collected by contract research organizations. Reports prepared by Dr. Wolfe are suitable for submission to the FDA.
Proposal Preparation (Commercial and Government) – With Dr. Wolfe’s significant expertise and network of contacts in government and industry, he is able to add significant value to the proposal-writing and review process.
Peer Review – Dr. Wolfe is qualified to critically analyze published reports. His analysis will both identify potential deficiencies in scientific validity and/or GLP compliance and provide recommendations to resolve such issues.
Standard Operating Procedure (SOPs) – In his experience in industry, Dr. Wolfe has authored a complete series of SOPs for a contract research organization offering a full suite of GLP-compliant services. Utilizing his expertise, Dr. Wolfe is able to review and document client procedures in a way that is compliant with FDA SOP format. In addition, Dr. Wolfe is able to review established client SOPs; offering recommendations that can improve function, remediate non-compliance, and/or ensure continued compliance.
Material Safety Data Sheet (MSDS) – Dr. Wolfe is experienced in preparing MSDSs for a broad range of compounds in addition to pharmaceuticals.
Literature Searches and Position Papers – Dr. Wolfe is adept at the collection of toxicology manuscripts available in the open scientific literature, including but not limited to PubMed, ToxNet, NTP, INCHEM, RTECS, and BIBRA databases. Dr. Wolfe is able to summarize collected manuscript findings into a position paper that addresses specific issues identified by clients or regulatory agencies.