Business and Facility Expansion
We recently completed a business and facility expansion at a secondary contract packager in the upper mid-west. The client expressed an interest in entering into primary filling of oral solids dosage OTC and Rx products and entrusted PharmAgility with leading their expansion. We responded with an innovative facility design that seamlessly integrated primary filling with their existing secondary packaging capabilities. The project included sourcing, installing, and qualifying the facility / equipment, assessing and upgrading the client’s quality system, recruiting and training new employees, marketing the new capability, passing inspection, and ultimately successfully transferring the first commercial product into the new facility.
The results? Amazing. Our consultants (we call them PharmAgicians) led the client from feasibility study to successful commercial production in just six months and the project has been featured in a number of industry magazines and journals.
Business Transformation / Waste Removal / Cost Reduction
Our consultants have also had dramatic success in removing waste and decreasing cost and time to market at multiple client sites. Our operational excellence and business optimization / transformation program has foundations in Lean and six sigma but also includes proven change management and critical cultural transformation strategies required for successful and sustainable results. Our experience proves that you win with people and our efforts are centered on teaching best practices during our business transformation efforts. The results generate employees who are adequately prepared to sustain the improvements beyond the end of the project and, most importantly, emerge fully capable of proper business process analysis and improvement so the requirements of the future can continue to be met.
We recently supported the development of a business model expansion for a contract research organization that specializes in the cGMP manufacture, lyophilization, and formulation development of parenteral sterile products. PharmAgility provided expert insight from both a business and regulatory perspective as industry and agency experienced consultants assisted the client’s executive leadership team in developing a growth strategy for successful expansion into full-scale commercial manufacture of parenteral sterile prescription and biological products. No two situations are the same and PharmAgility takes a proven, methodical approach to ensure that our strategic solutions are robust and practical in successfully shaping the future for our clients.
Our consultants have helped clients successfully prepare for health authority and prospective customer inspections. We have assisted clients with general cGXP, sterility assurance, investigations and CAPA, product and process remediation / transfer, analytical methods remediation / transfer, quality assurance oversight, and more. Our most recent client inspection concluded with a successful outcome that included no major / critical observations as a result of our readiness efforts.
Business and Supply Chain Management Optimization
We have installed balanced scorecard (BSC) and sales and operations planning (S&OP) processes that have improved inventory management, product launch management, operations planning, shop floor coordination and warehousing & distribution solutions. The global supply chain assessments and improved business processes led by our experts have cut cycle times and improved customer service levels while reducing inventory levels and costs.
ePedigree and Product Serialization
PharmAgility has partnered with industry leaders to successfully implement ePedigree and Product Serialization capable systems designed to successfully meet pending product track and trace requirements—most notably the state of California. PharmAgility has been in attendance at California Board of Pharmacy meetings to remain in tune and up to date with latest developments related to the state’s pending requirements and can help clients in successfully comply with the new regulations. And compliance does not have to be an added cost of doing business with little payback. PharmAgility combines its ePedigree and Product Serialization expertise with our Business Transformation / Waste Removal / Cost Reduction strategies to offer clients a unique opportunity to minimize the cost impacts of gaining compliance to the new requirements. We accomplish this by leveraging the data resulting from the product serialization system and combining it with our lean concepts in order to better tune the supply chain to remove waste, reduce costs, and optimize business results.
PharmAgility has provided contract staffing to clients in need of temporary support. We are able to quickly field bench chemists, technical writers, validation specialists, engineers, QA investigators, and more to provide clients the additional staff they need to overcome periods of high workload (i.e. compliance remediation, facility qualification and start-up, inspection readiness, etc.). Our clients enjoy the flexibility of adding additional capacity and expertise without expanding their permanent headcount.
That’s PharmAgility™ and that’s why we are the partner of choice for leading firms.