For NHP Submissions, the NHPD is involved in the process of reviewing and approving the finished product specifications. Q&R will prepare a report stating the final product specifications, including the identity, purity, potency and quantity of the medicinal ingredients. Our team will also review your labels to advise you on compliance with the NHP Regulations.
Q&R can accelerate preparation of your submissions utilizing the electronic submission system which provides quicker turn around for the submission number and subsequent NPN number. This system also reduces the possibility of the issuance of an IRN (Information Request Notice) or PDN (Processing Deficiency Notice) letters due to embedded rules while checking for specific regulatory requirements.