Our Services
Biopharm Consulting Services
Capabilities
As part of our Biopharm Consulting Services, Mangan Biopharm offers automation, validation, and engineering professionals with deep experience across regulated life sciences environments. Our biopharma engineering services team includes former industry employees and consultants with backgrounds in biopharmaceutical process R&D, manufacturing, plant design and startup, commissioning, validation, quality assurance, automation and control systems design, and capital project execution.
Experienced
With over 25 years of providing services to our Life Sciences clients, our personnel have the expertise to work with you on projects of all sizes. Regardless of project scope and size, Mangan Biopharm can provide expert professional services to deliver projects on time and on budget without sacrificing quality. Our clients become colleagues not opportunities.
Professional
With prior experience working for major pharmaceutical and biotechnology manufacturers in lead Engineering, Validation, and Quality roles, our highly trained personnel have successfully delivered GMP Compliance Services as well as non-GMP systems engineering, automation, commissioning, qualification, and validation projects for some of the largest pharmaceutical and biotechnology companies in the world.
What We Do
Mangan Biopharm’s Biopharm Consulting Services are designed to support clients throughout the project lifecycle, from early planning and engineering through commissioning, qualification, validation, regulatory readiness, and long-term compliance. Whether supporting a new facility, modifying an existing process, preparing for an audit, or addressing resource constraints, our team provides practical technical expertise backed by hands-on life sciences experience.
CQV Expertise
With much experience at several biopharm clients, we can benchmark your validation program against current industry standards or create a new custom program that fits your unique business model.
Sometimes new products or new processes create a gap in your resources and you need a trusted partner who can provide professional services to help fill that short term need. Mangan Biopharm offers professional staff that have been instrumental in completing qualification projects in preparation for new product introductions at some of the largest biopharmaceutical companies in the world.
A critical component of a quality system is a robust change control process that incorporates a thorough risk assessment. Mangan can help you perform process and product impact assessments to ensure the integrity of your product lifecycle is maintained.
Engineering Expertise
EPCM
Services We Offer
Our pharmaceutical validation consulting and CQV support help clients plan, document, execute, and maintain compliant systems across facilities, utilities, equipment, automation platforms, and manufacturing processes.
- Program Development
- Validation Master Planning
- CQV Project Management
- Greenfield and Existing Facility Modifications
- Integrated Commissioning and Qualification (ICQ)
- Automation, Control System & Data Historian
- FAT, SAT and Startup Support
- Equipment Qualification (learn more)
- Cleaning Validation (learn more)
- Sterilization (SIP, Autoclave, Terminal)
- Process Validation (learn more)
- Primary & Secondary Packaging and Serialization
- Cold Chain Shipping Validation
- Risk Assessments & Requalification
- Clean & Plant Utilities
- BMS, BAS & HVAC
Mangan Biopharm provides GMP compliance consulting and quality support to help life sciences organizations prepare for audits, evaluate risk, remediate observations, and maintain inspection-ready operations.
- Program / Procedure Development
- Regulatory Audits and Risk Assessment
- Regulator Audit Preparation & Management
- Facility and Systems Gap Analysis
- FMEA and Risk Assessments
- Failure Investigation Support and Review
- Regulatory Agency Audit Preparation
- Response Preparation
- Audit Observation Remediation
Our computer system validation consulting supports regulated software, computerized systems, and data integrity requirements across the system lifecycle.
- Roles and Responsibilities
- Risk Assessment Approach for Computerized Systems
- Process and Procedural Controls
- SDLC Methodology (GAMP5, etc.)
- Periodic Review Approach
- Testing Approach
- Data Integrity
- Change Control & Change Assessments
- 21 CFR Part 11/ EU Annex 11
- Training
- Record Retention/Archival
- System Decommissioning
- MES, ERP/MRP & LIMS
Our biopharmaceutical automation services help clients design, integrate, document, and maintain control systems that support reliable, compliant manufacturing operations.
- Control System Integration
- Project Management
- System Design, Engineering and Fabrication
- System Lifecycle Documentation Development and Execution
- Plant Wide Historization and Management
- DCS/PLC/HMI Programming and Implementation
- S-88 Batch Programming
- IT/IS Planning, Configuration and Implementation
- Hardware / Software Platforms:
- Allen-Bradley/Rockwell Platforms
- DeltaV
- BAS/BMS (Siemens, Rockwell, Honeywell)
- OSI Pi
- Intellution
- Wonderware
- Additions and Modifications to existing facilities
- New construction
- Capitol Project Management
- Construction Project Management
- Scheduling and Resource Management
- Equipment Procurement
- FAT and SAT Support
