PSC is a full service consulting business providing broad industry knowledge‚ expert advice and hands–on technical and business support to Medical‚ Food‚ CPG and Industrial companies. We work with your suppliers and business partners or we leverage our key resources to support any of your endeavors. We work out of our own offices and we also provide on–site support at your facilities to work alongside your employees. PSC provides advice or hands–on support from idea generation through to implementation and completion of a project. And‚ to limit your costs‚ we can quote specific activities and provide only the support and services that you want or need. Below are some of the areas we support. If you need assistance or just want to talk about options‚ contact us .
Audits, Recalls and Remediation
We prepare for regulatory compliance:
Risk and Gap assessment, CAPA guidance, Independent auditing, Root cause analysis, ISO 11607, ISO 13485, ISO 17025, ISO 9001, 21 CFR Part 820, Part 211, MDD, MDR, Sterile Barrier Systems, Aseptic Presentation and QMS
Coaching & Training
We mentor, teach, direct and advise:
Packaging Technology, Management
Skills, Build credible and respected
departments: recruiting, selecting, developing
people and the operating culture, Implement
change, Manage transitions, Coordinate
teams to increase value, performance
and project success rates
Cost Savings
We drive costs lower:
Increasing the speed to market, conducting cost/benefit analyses, reducing value chain cost of materials, processes and designs, considering best, worse and expected case scenarios, performing competitive analyses and benchmarking
Design & Development
We design from project inception to completion:
Generate ideas and concepts for products used from birth to death, consider waste from cradle to grave and deliver new or transform existing products, packages and systems
Logistics & Distribution
We develop optimal package systems:
Understanding the usage and transportation environments and customer and consumer requirements, products and containers are designed and tested for product fragility, shock, drop and vibration testing, integrity, temperature and climate exposure to prevent product damage and maintain product sterile barrier until receipt
Materials Compatibility
We figure out what works best:
Shelf life testing, Accelerated aging, product and package compatibility, acceptable barrier properties and suitability of material for achieving maximum equipment yield and performance
Package Equipment Installations
We successfully install equipment:
Write IQ/OQ/PQ protocols for testing and manufacturing equipment, execute protocols, analyze and report results
Product, Process & Quality
We satisfy customers and end-users:
Resolving performance, aesthetic and damage issues to increase capacity, revenue and decrease downtime, material costs and product returns using SPC and Six Sigma DMAIC approach, Lean manufacturing and by eliminating unnecessary work flow steps
Project Management
We launch projects on time:
Develop a detailed plan with project schedule, engage the team, update stakeholders, control costs, manage tasks, ensure design control and minimize risks.
Qualifications and Validations
We ensure integrity and efficacy:
Perform DOEs, conduct process capabilities, package design and equipment installation and process validations and test method validations to ensure quality control, assurance and regulatory compliance.
Research & Innovation
We investigate and experiment:
New technologies, materials, processes and develop prototypes, models, best practices, perform feasibility studies, engineering analyses, trend analyses and conduct audits
Specifications and Labeling
We document standards:
Packaging Components, Labeling, Processes, Maintenance and Work Instructions
Strategy Development
We define roadmaps for success:
Considering customers’ needs, behaviors, technology, trends and by selecting the right KPIs
Testing & Evaluations
We measure and ensure requirements:
Generating data for Protocol Studies, Shelf Life, Compression Strength, Physical Properties, Dimensional Analysis, Weight Gain/Loss, Stability Studies, Slack-Fill, Tensile/ Seal Strength, Package Integrity, First Articles, Quality Inspections
Troubleshooting
We apply our skills to solve problems:
Removing the issue or discovering the opportunity