M L A Baig

Biography

 Clinical Research professional with twenty years of experience in Indian multinational pharmaceutical companies. Robust background in bioanalytics, pharmacokinetics and biopharmaceutics. Strong scientific research capabilities and business acumen that drive effective laboratory operations and project management. Serve as a proactive leader and team collaborator, motivate staff and establish a cohesive environment focused on accountability. Ability to present complex information to diverse audiences as a technical subject matter expert (SME). Leading group of 40 analysts/scientists with nine LCMSMS and three HPLCs for cost effective bioanalytical method development, validation and clinical sample analysis to support organization’s ANDA/NDA program. Proven abilities in training, mentoring and motivating the team. Expertise in understanding and implementation of GLP, GCP, 21 CFR Part 11, IRB, Ethics committee,ICF etc as per international regulations. Completed > 500 BE studies for regulatory submissions to US FDA and UK MHRA.

Research Interest

 Established new Bioanalytical laboratory . This includes site selection, Laboratory design, Equipments purchase, Installation and qualification as per GLP, Recruitment and training of team, Creating systems and SOPs in conformance of GLP and international regulatory guidelines. Successfully faced US FDA, UK MHRA ,ANVISA, DCGI regulatory audits.