Sunil Acharya

Background

About Sunil Acharya

A competent individual with over 11 years and 8 months of experience in the areas of Generic Formulation Development of solid oral dosage forms for Regulated Markets like USA, EU. Specialized in Pelletization (Wurster process, Extruder and Spheronization),Granulation (fluid bed top spray,wet/dry, roller compaction),Direct compression and tablet coating which includes drug coating, DR coating,Film coating as well. Proficient in scale-up, technology transfer, and manufacturing of exhibit batches, ensuring seamless transition from R&D to production. My expertise spans the entire product lifecycle from preformulation and QbD-driven prototype development to technology transfer, scale-up, and regulatory submission support. I am adept at identifying critical process parameters, conducting bio-relevant dissolution studies, and executing stability studies in line with ICH and global regulatory standards and Evaluation and assessment of Nitrosamine impurity. Strong cross-functional collaborator with analytical, regulatory, QA, IPR, and production teams to drive timely project delivery. Hands-on experience with equipment qualification, technical documentation (BOM, MFR, BMR, BPR), PDR writing and QMS platform (Master Control, Veeva Vault, Trackwise) Skilled in regulatory support: addressing post-filing queries and preparing robust technical dossiers. Specialized in ANDA and 505(b)(2) submissions for solid orals, with hands-on experience in CGT and first-to-file (FTF) projects.