Chemistry, Manufacturing and Controls (CMC) Leadership
Product Management
Strategy and Operations
Helping organizations build and lead CMC teams, advance drug candidates from pre-clinical to commercialization by developing and implementing science, risk and Quality-by-Design (QbD) based Chemistry, Manufacturing and Controls (CMC) development strategies.
Inspiring and enabling teams to innovate and solve complex challenges across the drug development lifecycle.
30+ Patents Worldwide
Injectables, Opthalmics and Oral solid dosage forms
5+ IND, IMPD, NDAs, ANDAs
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Building and enabling CMC teams to help organizations grow and advance drugs from labs to the clinics to benefit patients
Understanding CMC development is key to building the right team structure to support the organizations’ growth strategy and vision
As a CMC team lead, I lead an interdisciplinary, matrix CMC team that includes; drug substance, drug product, analytical and device development, clinical manufacturing, packaging & supplies, regulatory and quality teams by designing, developing and implementing integrated phase-appropriate global CMC development strategies from phase 1 to commercialization.
How I can help
CMC Development Strategy
Enabling companies to take their lead candidate and/or assets in the portfolio from pre-clinical stage/ Phase 1 to commercialization by designing, developing and implementing Quality-by-Design (QbD) based phase-appropriate CMC strategy to better position the organization and teams for bringing their innovations to the patients.
Operations
Global clinical and commercial operations management by optimizing manufacturing strategy (internal and external networks), supply chain, product lifecycle management to help bring safe and innovative therapies to the patients quickly and efficiently.
Product/ Portfolio Management
Resource and budget allocations for the assets as they move form research into development space taking into consideration the disease/ therapy area, size and design of the clinical studies. Prioritizing the assets for development to maximize value creation potential for the organization and the patients.
Regulatory CMC
CMC Module 3 for investigational new drug (IND), investigational medicinal product dossier (IMPD), new drug applications (NDA) and abbreviated new drug applications (ANDA). Response strategy to the information requests from the regulatory agencies.
Risk Management
Risk management for drugs/assets under clinical development to ensure developability stage gates and continuous clinical supplies to the patients. Risk management consists of proactive risk identification, assessment, mitigation and contingency plans that encompasses across the CMC development work streams.
Quality and Compliance
Building a culture on quality principles and integrating it cross functionally throughout the organization is a competitive advantage, where teams are empowered and encouraged to design and develop products that keep raising the quality standards.
Dosage Forms
Injectables: Vials, Prefilled syringes/ Combination products, Infusion bags,
Ophthalmics: Blow fill seal (BFS), single-dose and multi-dose configurations
Oral solids: Tablets and capsules