Our Mission:
We collaborate with small to mid-size pharmaceutical and biotechnology companies during the clinical stage of drug development to provide expert solutions for optimizing their clinical supply chain operations. We lead or take our client’s lead to help them build clinical supply management expertise, develop outsourcing strategies, manage projects, improve compliance, and apply practical approaches for navigating the drug development process.
Spataro & Associates, Inc.
Maureen Spataro
Founder and President
Biography: Maureen has over 35 years of pharmaceutical industry experience having held positions in large pharmaceutical and “virtual” sponsor companies as well as in a contract manufacturing organization. She’s worked directly with clinical supplies for 28 of these years in many functional areas at levels ranging from clinical supply manufacturing technician to Vice President. As Vice President at AAIPharma, a provider of contract research and development services, Maureen was responsible for the leadership and management of the North American Manufacturing operation. In her previous position with AAI, as the Clinical Services Division Director, she was responsible for the clinical supply manufacturing and packaging operations and business development. At Nobex Corporation, a “virtual” drug development company specializing in peptide therapeutics, as the Senior Director of GMP Manufacturing and Compliance, Maureen led clinical supply outsourcing activities and was responsible for the development and oversight of Nobex’ quality systems. Over a 13 year period with Procter & Gamble Pharmaceutical, Maureen held various positions in R&D, regulatory affairs, quality assurance, and clinical supply operations. As the P&G Clinical Supply Group Leader, she was responsible for the in-house manufacturing and packaging operations, technology transfers, and outsourcing.
Let us not be content to wait and see what will happen, but give us the determination to make the right things happen.
-Philosophy of Life by Peter Marshall
She has developed and presented clinical supply and GMP compliance focused seminars since 1998 and was instrumental in the establishment of the Clinical Supplies Basics and Clinical Supplies Challenges programs sponsored by Pharmaceutical Training Seminars. Maureen’s publications include, “Contract Manufacturing and Packaging of Clinical Supplies,” in Drug Products for Clinical Trials (Markel Dekker, 1997), “Speed Dating: the Rapid Way to Phase I Clinical Studies,” PMPS Journal (Winter 2006), and “Investigational Product Change Control,” Applied Clinical Trials (August 1999) and Pharmaceutical Technology (October 1999). She is a member of the American Society of Quality, Drug Information Association, and the International Society for Pharmaceutical Engineers, where she was a Program Coordinator for the ISPE Carolina South Atlantic Chapter CTM Forum. She earned an AAS degree in Medical Laboratory Technology and a BS degree in Industrial Technology from the State University of New York.
Our Associates:
MWA offers a full range of consulting services in GCP, GLP, and GMP compliance for the pharmaceutical, biotechnology and medical device industries.
NDA is an International Pharmaceutical Manufacturing Consulting organization, improving pharmaceutical and biotechnology industry performance through world class, innovative manufacturing, operations, and supply chain solutions. They help pharmaceutical and biotechnology companies plan the successful launch of new products and establish the secure supply of existing products. They help companies understand their capacity requirements, establish robust capacity plans, develop business cases for new capital investments, and install new capacity world-wide.
- Pharmaceutical Partners, LLC
Pharmaceutical Partners is a consulting firm specializing in GMP, GLP, and GCP inspections and quality assurance document reviews. They help pharmaceutical and biotech companies evaluate raw material suppliers, API manufacturer's, investigational and commercial product contract manufacturers, and contract packagers. They support your Quality Assurance efforts to meet peak demand periods by reviewing SOPs, batch production records, validation reports, and technology transfer documentation.
With a sound knowledge of US FDA and European regulatory body regulations, TPAN Consulting offers expertise in chemical syntheses/process development, API/dosage form Technology Transfer, Quality Assurance, Quality Control, and Regulatory Affairs.