Jon Gottfried, Bsc., Cqa, Mba Email & Phone Number

OUR GOAL is to help you and your team to be successful. TekTeam provides skills to your organization to get ahead with proactive risk management and regulatory credibility for successful relationships.WE help identify opportunities and cost-saving strategies and avoid pitfalls such as: Customer Dissatisfaction Due to Product, Process or Poor Metrics, Customer Action Due to Compliance Issues, FDA or Other Regulatory Agency Action, Product RecallsTEKTEAM provides timely and cost-effective services that meet or exceed the client’s and regulatory authorities’ expectations at the lowest possible cost. We are patient and industry advocates, with a passion for innovative technologies that meet medical needs.OUR SERVICES cover the entire product life cycle, from early stages of strategic planning and R & D, through product design, registration, verification, validation, manufacturing, and distribution. TekTeam can also assist your organization with post market maintenance activities such as product or process improvements, as well as with corrective actions and associated regulatory compliance.YOUR ORGANIZATION can depend on usduring the phases of growth and expansion, such as evaluation and management of potential relationships ranging from mergers and acquisitions to supplier and contract relationships, providing your organization greater leverage and fewer headaches.OUR TEAM of highly experienced professionals has been successfully serving the medical industry since 1990. We are dedicated to provision solutions that improve the technology, safety, efficacy and cost of pharmaceuticals, biologics, and medical devices by assisting clients with the increasing demands and complexity of regulatory requirements, their interpretation, and implementation.WE SEEK to improve profitability for our clients by providing them with proactive technical and business guidance, putting our experience and knowledge to work in the following areas: Due Diligence, Pre & Post Market Strategy, Technology Assessment, Regulatory Intelligence, Marketing Strategy, FDA Submissions, Risk Management, Project Management, Government Negotiations, Executive Training, Compliance Issues: Warning Letters, Safeguard Clause, Consent Decree, Observations, Audits: QSR, cGXP, ISO, CE, Pre-Approval, Clinical Strategy, QMS, Publication Strategy, Technology Transfer, Clinical Protocol, Forms and Tools Development, Design, Process Equipment & Validation, Trial Management, Reimbursement.

Listed skills include Operational Planning, Quality Assurance, Validation, Writing, and 46 others.