Company Profile

We are one of the leading and reliable Regulatory Consultants across the Globe. We are specialized company with an Experienced, Multitasking, Capable & Confident team for taking up the complete Regulatory Project responsibility to offer you high speed regulatory services. Our Regulatory Services are tailored to meet client’s requirements and add value to their organization by minimizing both Time and Money spent 1. DMF (Preparation, Filling and Registration for API. Type II, III, IV. 3. Scale up and Tech. Transfer Projects for Finished Formulations. 4. Dossiers services (CTD’s, ACTD’s, eCTD’s etc). 5. Guidance for GMP, GCP, GLP and updation of same. EU / PICS GMP Audits. 6. Post submission query reply, Query solving & Experts opinion on same. 7. BA/BE Studies 8. COS/CEP Preparation / Submissions We have a team of 24 Pharmacists. We have proven track of offering these dossiers successfully in more than 42 countries including EU USA etc.