Simplifying the GMP Gray Area
GrayMatter Partners’ internal expertise and external network of facilities, suppliers and service providers, enables us to simplify complex challenges from concept to commercialization.
Business Strategy
GrayMatter Partners’ experienced entrepreneurs, enable the executive leadership of life science companies to strategically accelerate product development, while optimizing quality compliance, costs and operational excellence. Our services include interim/fractional C-Suite roles, manufacturing strategy development, risk management, capacity planning. build vs buy analyses, vendor/partner selection, due diligence and business audits.
GxP Compliance
GrayMatter Partners provides comprehensive regulatory compliance services across the product development lifecycle including Phase Appropriate Quality Management System Implementation, all aspects of Process Validation, Facility Design and Start-up, Training, Supplier Management and Inspection/Audit Readiness.
CMC Strategy
GrayMatter Partners offers comprehensive support for pharmaceutical product development, from early-stage pre-clinical phases through to registration. Collaborating closely with a network of CMC experts globally, we deliver technical content for various modalities, regulatory jurisdictions and phase of development. From choosing the right electronic systems, CROs and service providers to regulatory submissions and communications, we are able to provide customized CMC solutions based on our clients' specific need and phase of product development.
Innovation
GrayMatter Partners addresses challenges from concept to commercialization of life science products. Hybrid manufacturing models designed to cut development costs and AI-driven, product/process-specific training aimed at improving training consistency and reducing operator errors and some examples of our recent innovations. Our external collaborators consist of a network of CDMOs/CMOs, testing labs, equipment suppliers, real estate and construction management firms, allowing GrayMatter Partners to identify and develop innovative solutions to the industry's pressing challenges.
Our Team
Ravi Samavedam is a Biochemical Engineer with 25+ years of experience in the biopharma industry. His past experience includes Technical Operations and Quality roles at companies such as Baxter, Amgen and Shire, as well as 12 years at the Azzur Group growing the consulting business and as a founder of the Azzur Cleanrooms on Demand business vertical. Ravi's excels at phase-appropriate cGMP implementation, build vs buy evaluations, supplier management, capacity and launch planning and all aspects of the process validation lifecycle.
Scott Corbin has more than 35 years of experience in Facility Design, Construction, Commissioning, Qualification, Validation, Manufacturing Operations, Quality Assurance, Auditing and Training. His past experience includes manufacturing and quality roles at Genzyme (Sanofi), Lonza Biologics, and Burroughs-Welcome. Prior to GrayMatter, Scott was at the Azzur Group in leadership roles in the consulting and Cleanrooms on Demand verticals and is an ASQ and ISO 13485 certified auditor.
Dave Manku has over 30 years of experience in pharmaceutical manufacturing, engineering, plant expansions and all phases of validation, cGMP compliance and auditing. Experienced in the design, construction and start up (inception through routine operation) of cGMP compliant facilities for the manufacture of biopharmaceutical and food products including the development of quality systems, commissioning/validation, and process design/optimization. Experienced at implementing a risk based approach to optimize start up of new and/or modified facilities to streamline testing, thereby reducing costs and minimizing regulatory exposure.
Shaleen Parekh has over 25 years of experience in the biopharma industry with focus on cGMP quality, process validation, training and continuous improvement. Early in his career, he worked in roles in Validation, Process Engineering and served as the Head of Quality. He co-founded his first company in 2005 and merged the company in 2013. He has held multiple C-level positions and advised other companies on operations, quality and talent development.