Support solutions for compounding pharmacies
ViTalent leverages its vast experience in FDA compliance to help 503A & B compounding pharmacies achieve operational excellence.
Experience that benefits your growing pharmacy operations
Targeted focus on organizational and operational support
The compounding pharmacy space is experiencing tremendous growth! Often, this rate of growth introduces challenges that can go unaddressed as owners and leaders prioritize filling orders and managing the day-to-day business. As tenured business leaders and owners, ViTalent adds value by helping clients tackle organizational and operational challenges associated with growth and scale of their business. As we engage, our primary objective is to develop a roadmap for Operational Excellence and execute the plan. Our solutions focus on the following strategic areas of your operation.
Organizational Structure
Talent Solutions
Business Scale
M&A Integration
USP/FDA Workflow, Process Design, SOPs
Labeling
Metrics & KPI's
Receiving, Storage & Distribution
503A to 503B Transition
Quality assurance for high quality results
A quality assurance program is guided by written procedures that define responsibilities and practices that ensure compounded preparations are produced with quality attributes specific to USP Standards (795, 797 & 800) appropriate to meet the needs of patients and healthcare professionals. As pharmacies grow, USP standards change or pharmacies transition from 503A to 503B status, establishing a strong Quality Management System is paramount to success. From our experience in the most regulated environments, ViTalent possesses industry expertise to help organizations develop Quality Systems ensuring compliance to USP and FDA guidelines. Our knowledgeable team adds value focused on solutions in the following areas:
QMS System Development
USP & FDA cGMP Compliance
Standard Operating Procedures (SOPs) & Training
Testing & Validation
Cleaning & Safety Processes
Containers, Packaging, Repackaging, Labeling & Storage
End to end management of pharmacy and workflow management system implementation
Pharmacy management systems are essential to maintaining reliability, adhering to quality standards, and ensuring patient satisfaction. ViTalent understands software and system implementation and we leverage our experience to assist clients on the journey from system selection through launch and go live. ViTalent is platform agnostic, so we approach each engagement as unique, but learn on our processes and best practices to deliver solutions on time and within your budget.
Define Scope & Create Project Plan
Manage Proposal & Supplier Process
Manage Contracting & Software Selection
Lead Implementation Project Plan Execution
Configure & Integrate
Train & Adopt
Launch & Go Live
Access to experts and top talent is a differentiator in today’s business environment
ViTalent has roots in professional services providing subject matter expertise and talent solutions in highly regulated industries like pharma and biotech manufacturing, compounding pharmacies and food processing. Whether your needs are project based leveraging the experience of a consulting team or you need a talent acquisition partner to provide direct hire solutions, we add value through flexible talent solutions.
CONSULTING & STAFFING
Consulting Services for USP Process Compliance – 795, 797, 800
503A & 503B opportunity assessment including transition to full cGMP
Start Up / New Facility – Expense budget development, Facility Master Planning, Process Design, Construction Project Management, Commissioning & Validation
Facility, Utility, Clean Room Validation
483 Remediation Support
Quality Management Systems, SOP’s, Technical Writing and Training
Environment Monitoring Programs & Systems
Talent Acquisition & Staffing
Full Recruitment Process Outsourcing (RPO) services
Staffing; temporary part-time & full-time flexible staffing models
Contingent Based Talent Acquisition
Direct hire talent acquisition solutions – full lifecycle sourcing and recruiting
Our Partners in Compounding Pharmacy
As an advocate and trusted advisor for our clients, ViTalent has developed key strategic partnerships that deliver differentiated value across your project needs. Please contact us for more information on these organizations or to begin a conversation on how we can leverage these partnerships for your project.
Cleanrooms USA is a leading cleanroom design, construction and installation company. Cleanrooms USA offers a range of cleanroom partition systems and accessories, as well as provides turnkey cleanroom design and build. They come as pre-constructed, validated CGMP modular facilities.
Edge X offers advanced micro technology solutions for real-time monitoring and tracking, as well as environmental monitoring (temp, RH, pressure and more), inventory and asset tracking. Their systems are completely wireless and use visual USP compliance tracking and historical data.
Contact us today to learn how ViTalent can support your 503 A & B pharmacy
