A white paper is a comprehensive summary of the efficacy and safety of a specific ingredient/ substance in the target species, for a particular route of administration. The white paper is often an essential component of a regulatory submission, especially for an ingredient/ substance that is not well known to the regulators. PDA has extensive experience in the preparation of white papers that assist with product development and regulatory approvals.
PDA has an in-depth understanding of the regulations for human and animal health products. We produce product development plans that will satisfy regulatory requirements and ensure a smooth, seamless review process. PDA can prepare a comprehensive development plan that includes:
PDA has excellent contacts with contract manufacturing organizations within Canada that provide high value services to the human and animal health industries. These services include:
Working in collaboration with these partners, PDA can produce the overall manufacturing development plan and oversee the manufacturing development work to ensure activities stay on time and within budget.
PDA has extensive experience with the preparation of study protocols that meet Good Clinical Practice (GCP) standards for safety studies, efficacy studies and field studies. PDA can either prepare the study protocol, or review and comment on a study protocol that has been prepared by the company or a Contract Research Organization to ensure it adheres to GCP and other regulatory requirements. A well-designed study is essential to achieving the desired study outcome, and to ensure the study will meet regulatory requirements.
A study monitor is required for all GCP, pivotal studies and PDA offers Clinical Trial Monitoring services for these studies. PDA will be involved in the study from protocol preparation to the completion of the final report, and will ensure that the Study Investigator (and all other study personnel) adhere to the study protocol, correctly perform tests, accurately record data, properly administer and record test and control articles, and, carry out all study duties as per the protocol and standard operating procedures (SOPs). PDA will regularly communicate with the Study Investigator and visit the study site on multiple occasions throughout the study to verify data, observe during testing days, and ensure that study procedures are carried out correctly.