Offering Expert Solutions for the Pharmaceutical and Medical Device industries for Regulatory Compliance, Quality Systems, Patient Safety, and more.
Expert Medical Device & Pharma Solutions
With over 35 years of global experience in Medical Devices, Pharmaceuticals, Biotech, and Combination products, we understand your needs and resource challenges to provide sustainable solutions.
By understanding your areas of opportunities, collaborating on the alignment of risks, and prioritization of improvement areas, we develop action plans engaging the organization for sustainable resolution.
Regulatory Compliance and Quality Systems
We focus on developing an integrated approach for all elements of your Quality System from conception to post-market to meet the current and future needs of your organization.
Patient Safety And Risk Management
Taking a process approach, we integrate safety and risk management into developing decision-making, and organizational responsibility. Understanding that risk management and protecting the patients are the best ways to protect your bottom line.
Product Lifecycle Management
We specialize in Total Product Lifecycle system development: Concept, Development, Technical Transfer from R&D into Manufacturing, Production, and Post-Market Support. Establishing a process approach for proper communications and defined hand-offs.
Organizational Agility: Coaching and Mentoring
Trained and mentored over 200 quality and regulatory professionals from frontline managers to VPs, enhancing and developing their leadership and regulatory professional skills.