Dossiers are prepared by competent professionals as per the ACTD, CTD, eCTD, NeeS or any other country specific format not only for our own products, but also for our valued customers located in various parts of the world. eCTD Dossiers for the regulated markets are prepared on a dedicated application which complies to highest regulatory standards including the Title 21 of Code of Federal Regulations Part 11.

Milan Laboratories acts a Regulatory Consultant for many pharmaceutical companies in the African continent where the demand for Regulatory Affairs has developed over a period of time. Services are offered for building new pharmaceutical factories as per EU-GMP & US-FDA standards, developing a pharmaceutical packaging depending on the country’s guidelines, etc.

The growing emphasis on quality combined with stringent regulatory norms and rising demand for better control, have made Regulatory Affairs vital and of the essence to any pharmaceutical industry.


The Regulatory Affairs department at Milan Laboratories keeps track of the ever-changing scenario and legislations in the pharmaceutical world and in turn advise on the scientific requirements and legal issues therein.