Our projects involve a range of skills. If we can’t help you, we use our contacts to find the needed skills.
• Conduct GMP audits of manufacturing, packaging, and distribution sites for a global pharmaceutical, vaccines, diagnostics, and medical device firm
• Evaluate analytical chemical and manufacturing validation packages for three NCEs. Identify and resolve deficiencies, write up regulatory packages for submission to FDA.
• Provide scientific justification for advertising false claims lawsuit.
• Evaluate global competition and patent position for new dietary supplement. Provide market insight to business potential and entry strategies.
• Provide on-call formulation guidance to strategic customers of food ingredient distributors.
• Audit and provide recommendations for CROs under consideration as clinical and bio-analytical sites.
• Develop and execute DOE/QbD approaches to solve multi-factor problems. Determine critical factors for management.
• Provide scientific strategy for patent infringement lawsuits.