Indira Walker serves as the Director and Principal Consultant at Iolite Pharma Consulting Limited, where she leverages her extensive expertise in Quality Assurance (QA) and Regulatory Affairs to guide pharmaceutical and medical device companies through complex regulatory landscapes. With a robust background in Contract Development...
Indira Walker serves as the Director and Principal Consultant at Iolite Pharma Consulting Limited, where she leverages her extensive expertise in Quality Assurance (QA) and Regulatory Affairs to guide pharmaceutical and medical device companies through complex regulatory landscapes. With a robust background in Contract Development and Manufacturing Organizations (CDMOs), Indira excels in the selection, leadership, management, and auditing of these critical partnerships, ensuring compliance with stringent regulatory requirements across various markets, including the UK, EU, Far East, and US.
Her comprehensive experience encompasses a wide range of dosage forms, including Advanced Therapy Medicinal Products (ATMP), biopharmaceuticals, sterile products, solid doses, inhalation therapies, and topical formulations such as creams and ointments. As a Qualified Person (QP) for both human and veterinary products, Indira is adept at navigating the intricacies of Good Manufacturing Practice (GMP) and has been deemed eligible by the Medicines and Healthcare products Regulatory Agency (MHRA) to act in this capacity.
At Iolite, Indira leads key projects that focus on enhancing quality systems and streamlining regulatory processes, ensuring that clients not only meet compliance standards but also achieve operational excellence. Her skills in auditing, clinical trials, and change management are instrumental in developing Standard Operating Procedures (SOPs) that align with both FDA and European Medicines Agency (EMA) guidelines. Indira’s commitment to fostering a culture of quality and compliance positions Iolite Pharma Consulting as a trusted partner in the pharmaceutical and healthcare sectors, driving innovation while safeguarding patient safety.
