Given the scope and complexity of IDMP, xEVMPD, MDR, and UDI compliance, Celegence not only prepares organizations to become regulatory compliant with changing regulations by helping companies collect, convert, and report relevant data; but also, provides strategic support by providing regulatory consultants who can support organizations put in place broader regulatory information management strategies.
As Identification of Medicinal Products (IDMP) comes into the horizon for the industry, Celegence is offering both a short term and a long-term strategic approach to respond to regulatory requirements and establish broader benefits for businesses. Our experience in regulatory operations and xEVMPD submissions enable Celegence to help companies prepare for all iterations of IDMP. We can support companies with readiness assessment, IT and submission strategies, mapping of current xEVMPD fields to IDMP iteration 1 fields and ISO IDMP training.
Our UDI compliance services allow us to manage your medical device product data and distribute it seamlessly to regulatory authorities. Expert Celegence regulatory consultants work with your regulatory team to smoothly navigate each stage of UDI data submission. Our team will help device companies collect and validate their UDI data, build UDI records in HL7 Structured Product Labeling format, submit electronically to the FDA’s Global Unique Device Identifier database and perform ongoing record lifecycle management. Celegence also focuses on regulations for new medical devices globally to help organizations assess their readiness in terms of data, processes, and systems to be compliant with new regulations such as EU MDR and UDI.