Chaitanya Boddu Email and Phone Number

Expertise in the development of generic formulations especially solid orals such as tablets and capsules, Oral Suspensions, Powder for Oral Suspensions, Oral Solutions and Topical Lotions meeting FDA regulations and guidance & as per cGMP guidelines. Performed pre-formulation activities like Reverse engineering including characterization of RLD to identify critical attributes of RLDInvolved in API, excipients and even equipment procurement for batch manufacturing.Optimized the blending process to achieve acceptable BU and CU results on pre-validation batches.Coordinating with the analytical lab in performing the split study of scored tablets, hold time studies as per the protocols.Identification of container closure configuration and need for specialized handling/packagingDefined quality target product profile (QTPP) and identified the critical quality attributes (CQA) required to meet the product performanceExecution of stability studies as per the regulatory guidelines and preparation of stability protocols & reports.Extensive experience in successful transfer of technology from the lab to manufacturing and guiding in stabilizing commercial production in collaboration with Analytical Development and Validations, Quality Control and Quality Assurance. Proficient in techniques such as blending, granulation, roller compaction, high shear mixer granulation, drying, milling, compression as well as encapsulationThorough knowledge of Process Scale-up and Validations and preparation of the validation protocols for exhibit and scale up batches.Expertise in the authoring the regulatory documentation PDR, QOS, Batch formula, Exhibit batch-Scale up equipment comparison, BMR, BPR, yield & reconciliation, IIG MDI justification as per IID limits etc.Developed and assisted Regulatory affairs team in successful filing of 07 ANDA’s that include oral solids dosage forms, suspension, solution and Topical Lotion.

Meeting doctors and explaining new developments of our company products and arranging meetings between company officials and doctors. It helped me develop my communication skills and gain confidence to interact with new people.