Vishal Daga Email & Phone Number

Led formulation development of Oral Solids (IR, SR/ER), Injectable, Semisolid, and Liquid products for US, EU, and Canada markets, enhancing product stability and compliance with FDA, EMA, and Health Canada standards.Successfully led cross-functional collaboration with analytical, regulatory and manufacturing teams, optimizing process flow and reducing lead times through effective teamwork and independent task management.Oversaw formulation development projects with CDMO/CMO partners for various drug formulations and medical devices, ensuring adherence to timelines and regulatory standards.Demonstrated strong personal accountability by independently managing high­ stakes formulation projects.Thrived in high-paced environments, managing overlapping project timelines and troubleshooting formulation issues swiftly to meet critical submission deadlines in a competitive R&D landscape.Directed and finalized formulation strategies for new product launches, leveraging QbD and DoE to optimize stability and efficacy, which reduced formulation adjustments in later phases by 20%.Led prototype formulation development, formula optimization (QBD, DoE), and stability testing.Developed robust product specifications aligning with ICH and pharmacopoeia! standards, ensuring regulatory compliance and consistent quality for each market-specific product variant.Spearheaded technology transfer and troubleshooting for commercial-scale production, resolving scale-up issues.Provided expert regulatory support for dossier filings, proactively addressing queries.Championed continuous improvement initiatives, optimizing formulation protocols and documentation.Led troubleshooting and site transfer for commercialized products, implementing solutions that minimized production downtime and improved batch quality consistency.

Hyderabad, Telangana, India

Successfully developed and filed multiple bioequivalent Para-IV and NCE-1 products, meeting global regulatory standards for U.S. and EU markets.Conducted comprehensive literature reviews and designed innovative experiments, employing strategic patent circumvention techniques that facilitated the market entry of complex generics within competitive timelines.Spearheaded API and excipient sourcing, innovator product procurement.Defined Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) and utilized Design of Experiment (DoE) principles to optimize product quality.Led bench-scale development trials, iterating prototypes to refine product characteristics and achieve targeted stability and efficacy outcomes in line with QbD standards.Prepared and maintained master documents (e.g., Stability Protocol, PDR, BOM, MFR, Pilot batch BMR), streamlining documentation for regulatory audits and improving accessibility for cross-functional teams.Compiled comprehensive pharmaceutical development reports aligned with QbD guidelines, ensuring regulatory readiness and facilitating smoother approval processes for submissions in U.S. and EU markets.Collaborated effectively with Analytical, IPR, Regulatory Affairs, PKPD, and Packaging teams, ensuring cohesive project updates and alignment, which reduced project cycle times and facilitated faster regulatory submissions.

Aurangabad Area, India

Formulation and development of oral extended release dosage forms for regulated markets (US and Europe).In depth patent analysis and development of patent non-infringing strategies for formulation development in coordination with IPR team.Scale-up, technology transfer and execution, stability study design of pivotal batches at manufacturing locations.Development of concept based extended release formulations with consideration of QbD norms.Handling of NCE's for preformulation studies, formulation development activities for clinical trials.Strategic development of cost effective formulations.

M Pharm, Pharmaceutic

Bachelor Of Pharmacy