Vakils’ Regulatory Specialised Service
What are Vakils’ regulatory specialised services?
Vakils manages the process of review for regulatory documents and the implementation of label changes as per approved documents.
What should you know about Vakils’ regulatory specialised services such as BPS?
At Vakils, we perform regulatory content reviews and formatting checks as per SRPI and QRD (CCDS, USPI and EUPI accompanied with secondary documents such as CPPI, Patient Guide/Medication Guide and Patient Labelling Information).
How is this service interlinked with artwork/labelling changes?
Once approved, FDA/EMA manuscript gets converted into packaging artwork.
Any post-marketing changes in CCDS (marketing company), reflects in USPI (insert) and EUPI SmPC as booklets and Annex IIIA – labelling in cartons, labels, etc. Thus, this customised workflow process is interlinked artwork/labelling changes.
Why should you choose Vakils? What are the benefits to customers?
- Our team is experienced in reviewing the required documents: FDA – SRPI/SmPC – QRD 10.2
- BPS and artwork teams work closely and coordinate with each other
- Our simple workflow is applied from the approved content migration into packaging artworks
- We offer automation of word templates, which help in efficiency, saving time and cost
How does Vakils define customer satisfaction?
At Vakils, we strive to provide powerful solutions and flawless execution, in order to unlock the productivity and efficiency within our client’s marketing communication operations.
We are able to deliver on this by consistently ensuring that we stay customer focused, professional, dependable, attentive, genuine, empowering and open.
At Vakils, we focus on effective communication and prompt response times. We believe in right first time and do not compromise on the quality of any product or service. We provide cost effective solutions coupled with service excellence. We take pride in our work and are committed to deliver quality that meets (if not exceeds) expectations and quick turnaround times. Ultimately, we see our client’s success as our success.
