A regulatory Management service is the second most import part of product life cycle. Regulatory is our competency are and we started regulatory services in 2009.We rendered regulatory services globally. We are competent enough to compile Regional dossier, ACTD dossier, CTD dossier and e-CTD dossier. We are equally competent in filing dossier as per the need for various drug regulatory agencies.
We have gained experience over the time in resolving queries issued by drug regulatory agencies to register the product in various countries. AstraClinical regulatory manager works closely with the Quality Assurance Manager, Quality Control Manager to get the quality data from manufacturing plant. Our regulatory manager coordinates with Artwork development manager of the manufacturing plant and guide them up as how to develop Mono Carton, Label, Foil, Leaflet and Summary of product characteristics. Specially Mono Carton, Label and Foil varies country to country for example CIS countries do not require USP, BP, IP, JP or EP in artwork and if somebody add up Pharmacopeial symbol then artwork will be rejected.
Our regulatory manager trains our client’s regulatory team for better coordination and communication to compile the dossier on time. Currently most of the companies have their in house regulatory team but not Pharmacovigilance, Clinical and Bioclinical team. Noteworthy most of the regulatory agencies started demanding RMP, PSUR, PBRERs, PADERs, PSMF and SOP of pharmacovigilance. Clinical Trials and Bioequivalence Study. Most of the Regulatory Managers hardly understand these terminologies and they are not aware about pharmacovigilance and clinical trials. Regulatory manager alone cannot handle filing of dossier and query resolution hence they require outsourcing of dossier and filing to save time and reputation of the organization.
AstraClinical is the only company in the world who takes care compete product life cycle of a medicinal product. We have separate team for Regulatory Affairs Services, Clinical Data Management Services, Product Management Services, Pharmacovigilance Services and Medical Communication. Hence we the best suit to care your complete services under single umbrella.
Our Regulatory Manager are experienced in dossier compilation, dossier filing, Analytical Method Validation review, Comparative Dissolution review, Drug Master File review, Clinical Trial review, Bioequivalence review and Pharmacovigilance documents review. Our association will give you sense of security for return on investment and registration of medicinal product on timely manner.