Muhammad Mudassar Ali

Skills

Advanced R&D & Formulation Development
• New Product Development (NPD) – generics & value-added formulations
• Formulation design: IR, MR, multilayer, ODT, sachets, suspensions, injectables
• Pre-formulation studies & excipient compatibility
• QbD-based formulation approach & risk assessment
• SeDeM ODT Expert System application
• Bio-relevant & comparative dissolution studies
• Troubleshooting formulation & process-related failures
Scale-Up, Tech Transfer & Commercialization
• Lab-to-pilot-to-commercial scale-up
• Technology transfer (R&D → Production → Commercial)
• Process optimization & robustness enhancement
• Pilot, exhibit & validation batch execution
• Post-launch product performance monitoring
Product Lifecycle & Innovation Management
• Product lifecycle management (PLM)
• Cost optimization through formulation redesign
• API & excipient vendor evaluation
• Line extensions & reformulation projects
• Obsolescence management & continuous improvement
Validation & Quality Integration
• Process validation & cleaning validation support
• Equipment qualification coordination (IQ/OQ/PQ)
• Deviation investigation & root cause analysis
• CAPA, change control & risk assessments
• Audit readiness & regulatory inspection support
Regulatory Affairs & Scientific Documentation
• CTD Module 3 (Quality) authoring & review
• Drug registration dossiers (Form 5 / 5D)
• Stability study design & evaluation (ICH Q1A–Q1E)
• Post-approval changes & variations
• Regulatory query response coordination
Leadership & R&D Operations
• R&D team leadership, mentoring & performance management
• Cross-functional collaboration (QA, QC, RA, Production, Engineering)
• Project planning, timelines & resource allocation
• R&D budgeting & cost control
• SOP development & R&D compliance systems

About

Industrial Pharmacist with 10+ years of experience in pharmaceutical R&D, production, and technology transfer across solid, liquid, injectable, and semisolid dosage forms. Strong background in cGMP compliance, CTD documentation, process optimization, and regulatory coordination. Proven ability to lead cross-functional teams, support audits, and bring products from development to commercial scale in regulated environments.