Regcure Pharma

Regcure Pharma Regulatory Affairs Consultants is a leading and trusted regulatory affairs consultancy firm specializing in the pharmaceutical industry. With a team of highly experienced professionals, we offer comprehensive regulatory services to pharmaceutical companies, ensuring compliance with national and international regulations. Regcure Pharma will help you sail through complex requirements with ease. We can help with the following Regulatory Activities: Dossier preparations and New Product Development: Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD format & ACTD Format). Assistance in Administrative documents, Submission with MOH, and Post submission Support/Handling of Queries. Active Substances: DMF/ASMF/CEP: Regcure Pharma provides proficient solutions to make accurate submissions using available data and Documents, with well-organized technical writing and submission of DMF/ASMF for our clients globally. All documents and data required for the DMF submissions are evaluated and aligned as per the international requirements and guidelines. We offer customized services for advice and complete project management for filing of: Applicants (Open) Part DMF & Restricted (Closed) Part DMF CEP: EDMF/ASMF (Applicants and Restricted Part) for EU. Clinical Services: Preclinical and clinical overviews writing through literature search / published studies/articles from journals from different sources. Our clinical services are a hub for all from managing and monitoring Clinical trials in a wide range of therapeutic areas and monitoring BE studies in India, aid in medical writing and Clinical studies, Bio-availability and Bio-equivalence Studies, Clinical Trial Studies, Analytical Solutions, Preparing PSUR, RMP and Preclinical studies like Toxicity, Carcinogenicity, and Teratology & Reproduction toxicity to Therapeutic Justifications for FDCs.