Empowering Pharma with Expert Regulatory Guidance
Ratna BioPharms, offers comprehensive global Regulatory Affairs services for every phase of drug, API, and healthcare product development. We are your trusted partner in navigating regulatory pathways and ensuring compliance, delivering quality solutions that enhance global health. Our reliable expertise guarantees the smooth lifecycle management of your products across international markets
Global Regulatory Services
Our team of experts is well aware of your needs as well as the needs of regulatory authorities. To attain quick, hassle free registration of dossiers, a comprehensive registration knowledge and interpretation of guidelines is most warranted. Pharmaceutical dossier preparation services form an important part of our role in navigating customers through drug development.
Regulatory Affairs Services play a vital role in ensuring the successful development and commercialization of drugs as they navigate the complex and ever-changing landscape of Global Health Authorities (HA). Ensuring compliance throughout the process is a mandatory requirement. To avoid overlooking procedures across the product life cycle, organizations deploy proven experts for Regulatory Affairs Services . The expert team acts as a crucial link between the organization and global HAs, tracking all the key regulations related to the product and prerequisites for its launch.
Comprehensive Regulatory Support for Global Markets
Therefore We are offering dossier as per CTD/ACTD/ non-CTD (country specific guideline). Ratna BioPharms offers supportive services of medical writing to pharmaceutical companies as follows:
- 1. Ratna BioPharms writing Dossier in required format for registering the products in world wide markets like CIS, ASEAN and ROW countries in CTD, ACTD format and as per country specific guidelines for any dosage form.
- 2. Drug Master File (DMF) compilation for open and closed part, Provide support in conducting Structural elucidation of substances, impurity profiling and related validations and stability studies.
- 3. Preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.
- 4. Periodic Safety Update Report (PSUR) preparation. Provide support in responding to queries from Regulatory Agencies.
- 5. Monitoring and liaisoning with the CRO’s for PV or PhV (Pharmacovigilance Study Report) & BA/BE ( Bioavailability /Bioequivalence) Studies Reports.
