919-827-0933

Our Services

Mangan Biopharm offers personnel who can deliver specialty Life Sciences services, including GMP System commissioning, qualification & validation of facilities, utilities, equipment, and processes for the heavily-regulated Biopharmaceutical Industry.

Capabilities

We offer automation and validation staff who are experts in their trades, consisting of a mix of former industry employees and consultants from around the country. Their breadth of industry experiences range from biopharmaceutical process R&D, manufacturing, plant design and startup, commissioning, validation, quality assurance, automation and control systems design, and implementation and management of capital projects. 

Experienced

After twenty years of providing services to our 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.

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 Systems commissioning, qualification, and validation projects for some of the largest pharmaceutical and biotechnology companies in the world.

What we Do

CQV Expertise

Policies & Procedures 

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.

Policies & Procedures 

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.

Project Execution

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.

Change Control & Assessments

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. 

SERVICES WE OFFER

Commissioning, Qualification and Validation Services
Compliance and Quality Services
  • 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 
Contract Organization Support
  • Surveillance Audits
  • Regulatory Agency Observation Follow Up
  • Program Review / Auditing
  • Manufacturing Oversight (Customer Representation)
  • Failure Investigation Support
  • Cleaning and Process Validation Support
Automation and Integration Services
  • 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:
    • Ignition
    • Allen-Bradley/Rockwell Platforms
    • DeltaV
    • BAS/BMS (Seimens, Rockwell, Honeywell)
    • OSI Pi
    • ABB
    • GE Intelligent Platforms
    • Wonderware
Project Management
  • Additions and Modifications to existing facilities
  • New construction
  • Capitol Project Management
  • Construction Project Management
  • Scheduling and Resource Management
  • Equipment Procurement
  • FAT and SAT Support

Particle Monitoring System Integration

Client: Major Global Pharmaceutical Corporation Project Duration: 3 months Overview: Mangan was contracted as a final attempt to integrate an automated particle monitoring system for a large pharmaceutical manufacturing facility, located in the Eastern USA Three...

Facility Expansion/Modification

Client: Major Global Pharmaceutical Corporation Project Duration: 12 months Overview: Mangan was contracted to provide integrated Commissioning and Qualification services for a large pharmaceutical manufacturing facility, located in the Eastern USA Scope included: ...

Autoclave Revalidation Project

Autoclave Revalidation Project Duration- 9 months Overview During a concurrent project onsite at a major international pharmaceutical corporation, Mangan personnel were asked to evaluate the client’s Autoclave Program as a result of a regulatory audit.  Our existing...

Control System Upgrade: Lyophilizers

Control System Upgrade for Production Lyophilizers Duration- 6 months Overview: Upgrade the existing control system for production lyophilizers at a large biotech company. Scope of Work: The project scope included: PLC and HMI Upgrade for Multiple Lyophilizers...

Process Development Laboratory CQ&V

Process Development Laboratory Commissioning, Qualification and Validation Duration- 14 months Overview: Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new PD laboratory, within an existing biopharmaceutical commercial/clinical...

Clinical Manufacturing Suite and QC Laboratory Buildup

Clinical Manufacturing Suite and QC Laboratory Buildup Duration- 12 months Overview Built and started a clinical manufacturing suite and supporting QC laboratory for a clinical stage pharmaceutical company.  The engineering scope of work involved process, mechanical...

Cell Culture & Purification Manufacturing Suites CQ&V

Cell Culture & Purification Suites Commissioning, Qualification and Validation Duration- 12 months Overview: Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new Cell Culture and Purification manufacturing suites within an existing...

Bulk Complex Formulation Suite Commissioning & Qualification Support

Bulk Formulation Commissioning and Qualification Project Management

“Mangan delivers on their projects with talented resources and the technical know how to offer solutions to problems instead of waiting on us to solve them.  I appreciate their dedication and willingness to do what it takes.”

-Client A

“We had some unexpected challenges that consumed our internal resources at the same time a critical project was in progress.  Mangan stepped in and provided several validation engineers to fill the gap.  Great job guys!”

-Client B

“A trusted partner is often difficult to find.  With Mangan, we have been pleased with their responsiveness and overall quality of their staff.  What started as one small project has grown into a trusted partnership.. “

-Client C

Mangan Biopharm Cary

Mangan Biopharm Boulder

Mangan Biopharm West

Mangan Biopharm Northeast

Contact Us

If we can help you in any way, please complete the  More Information form and one of our specialists will contact you to discuss your specific needs and how Mangan can help you achieve your project goals.

West Region

trahimian@manganinc.com

(310) 835-8080 Ext. 217

3901 Via Oro, Long Beach, CA 90810

Eastern and Midwest Regions

mtedder@manganinc.com

(919) 827-0933

201 Shannon Oaks Circle Suite 125 Cary, NC 27511

For More Information: