Professional Nonclinical Services
Discipline-specific expertise in key nonclinical areas such as toxicology, veterinary pathology, pharmacology, pharmacokinetics, and regulatory affairs (strategic and operational) is available to Paracelsus clients through highly knowledgeable and experienced professionals.
Regulatory/Submission-Level Document Writing and Review
Paracelsus professionals deliver timely, high-quality nonclinical (pharmacology, pharmacokinetics and toxicology) contributions to global regulatory submissions including pre-IND Information Packages, INDs/CTAs, Periodic Regulatory Reports (e.g., IND/NDA Annual Reports, PSURs), Investigator’s Brochures and global product labeling documents.
Regulatory Affairs and Communication
Paracelsus expertise is available to liaise between Sponsors and global Health Authorities (e.g., U.S. FDA, Health Canada, EMEA), to prepare documentation for formal meetings with regulatory agencies, to negotiate and communicate effectively with regulatory authorities, to provide direction, leadership and technical expertise concerning relevant regulatory requirements and processes, and to ensure that client drug development programs are conducted in full compliance with all regional regulatory requirements.
Additionally, Paracelsus’ team of highly experienced professionals is available to assist clients in determining the need for and value of pre-IND (and other PDUFA) meetings, to conduct associated gap analyses identifying areas of potential weakness in development programs, and to establish contacts, prepare documentation for and represent clients at pre-IND (and other PDUFA) meetings.
Regulatory Operations (Submission)
Preparation and delivery of high-quality, timely regulatory submissions is a team effort! Paracelsus is available to provide project team management support as well as compilation, publishing and submission expertise.