Regulatory Affairs

PharmaZell employs a team of highly trained regulatory experts at each of its sites, who provide regulatory support to the customers in their ANDA, NDA and IND filings by producing stability reports, Drug Master Files and Certificates of Conformity for European Pharmacopeia (CEP). Our experience with a range of global regulatory submissions in countries worldwide including variations and change management assist the customers in quickly and effectively moving their drug products from development initiatives through the regulatory application and the review process.