OUR SERVICES
Biomanufacturing
Strategy and Execution
Services
Quality, Compliance and Regulatory Program Development
We offer a range of quality, compliance and regulatory services
- Quality Assurance Lead Backfill
- Vendor Auditing (CMOs, Equipment Supplier Computer, IT)
- Compliance Remediation
- CMO Management, Quality Agreements, Person In Plant
- CMO Capacity and Feasibility Analysis
- Quality Risk Assessment
- NC & CAPA Ownership
- Investigation & Root Cause Analysis Program Implementation
- Regulatory Strategy & Submissions
- Regulatory Inspection Preparation & Readiness
- Audit Preparation & Support
Validation Services
Our experienced validation team will document the consistency, quality, and accuracy of your systems, methods, and processes. We understand the different validation requirements for GMP, GLP, and GCP systems and the best ways to ensure compliance with FDA, EMA, and other global regulations.
- Traditional Commissioning and Qualification
- Validation Program Development
- Process Validation
- Computer Validation
- Cleaning Validation
- Steaming Validation
- Laboratory Validation
Strategy
Pharma Excel Tech has tremendous experience in providing business and manufacturing strategy to early-stage startups, established life science companies, leading medical institutions and CROs/CMOs. Our team can not only help define and develop the strategy for our partners but also execute the strategy with confidence!
- GMP Infrastructure and Startup
- Talent Sourcing and Human Resources
- Business Manufacturing Advisement
- Financial and Project Controls
- Program Management
- Marketing
Engineering, Automation and Serialization / Track & Trace
We are a versatile system integrator providing turnkey engineering services to fulfill our partner’s specific needs. Our professionals apply years of expertise to accomplish the most challenging engineering and automation tasks. Leveraging established industry best practices, PF provides customized solutions for successful project delivery. We also have subject matter expertise in small and large molecule facility builds, equipment and technology (modular cleanroom, single-use, serialization / track and trace and more). Our services and experience include:
- Preliminary, Conceptual & Detailed Design
- Facility Design (Greenfield, Brownfield)
- URS, FS, DS
- Construction Management
- Equipment Design, Selection & Procurement
- Vendor Management
- Asset Management
- Change Control Ownership
- Automation & Integration
- Part 11 Compliance
- Facility Utilities, Mechanical, Electrical & Plumbing (MEP)
- Reliability & Maintenance
- System Owner & Process Engineering
