Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Medical Device, Radio-Pharmaceutical Quality and Compliance Consulting   

Pharmabiodevice Consulting LLC provides an excellent consultancy with the help of several industry renowned Subject Matter Experts (SMEs) in the following areas:

Environmental Monitoring Operations Consultancy:

• Creating Environmental Monitoring Programs for a New and Existing Facility Validation
• Environmental Monitoring Data Management
• Environmental Monitoring Excursion Investigation Program
• Environmental Monitoring Programs
• Environmental Monitoring Remediation Process
• Environmental Monitoring Trend Reporting

• Establishment and Creation of a Laboratory Information Management System (LIMS) for a Quality Control Laboratory

• Quality Control Data Management

Compliance Remediation Services and Consultancy:

• FDA Warning Letters
• Routine Form 483 Corrective Actions
• Consent Decree Remediation Work

Cleanroom Contamination Control Practices Consultancy:

• Creating Disinfection Programs
• Validating and Qualifying Disinfectants (Disinfectant Qualification for New and Existing Disinfectants and Sanitizers)

 Production and Process Controls Consultancy:

• Aseptic Practices and Programs
• Cleanroom Personnel Behaviors and Practices Program
• Cleanroom Traffic Processes
• Personnel, Gowning Practices and Program
• Personnel and Product Flows
  
  

Product Release QC Testing Consultancy:

• Creation of Programs Associated with:
  
  • All Quality Control Testing Procedures
  • Bacteriostasis and Fungistasis Testing Program
  • Bacteria Endotoxin (LAL) Programs and Validation Tests, Biological Indicators Qualification and Testing Programs
  • Bioburden Testing
  • Conductivity Testing Program
  • Growth Promotion Testing Program
  • Materials Controls Program
  • Microbial Identification Programs (Phenotypic and Genotypic Testing)
  • Osmolality Testing Program
  • pH Testing Program
  • Product Identity Testing
  • Product Potency Assays
  • Sterility Testing Program
  • Tissue Culture Assays
    
    

Cleanroom Utility Program (Water Systems) Consultancy:

• Design of a New and Modification of Existing Water Systems:
  
  • Cleansteam System
  • Distilled Water System
  • Reverse Osmosis (RO)
  • Water for Injection (WFI)

• Designing the Protocols and Reports for the Validation of Water System
• Designing the Water Systems Testing Programs
• Validation Guidance for all Water Systems
  
  

Cleanroom Utility Program (Gas Systems) Consultancy:

• Design of a New and Modification of Existing Gas Systems:
  
  • Argon Gas
  • Compressed Air
  • Nitrogen Gas

• Designing the Protocols and Reports for the Validation of Gas System
• Designing the Gas Systems Testing Programs
• Validation Guidance for all Gas Systems
  
  

Stability Program Consultancy:

• Accelerated Aging Design and Testing
• Design of Stability Data Management and Trending
• Design of Stability Program for New and Existing Product
• Design of Stability Protocols and Reports
  
  

Raw Material Receipt and Qualification Program Consultancy:

• Design of Raw Material Inventory System
• Raw Materials Receipt and Specification Processing
• Raw Material Qualification and cGMP Requirement
  
  

Sterilization Validation and Routine Testing Consultancy:

• Biocompatibility Testing
• E-beam Sterilization
• Ethylene Oxide Sterilization
• Steam and Dry Heat Sterilization
• Vaporized Hydrogen Peroxide (VHP) Sterilization
• Radiation Sterilization
  
  

Cleanroom Facility Design and Validation Consultancy:

• Air Exchange Requirements
• Creating a Basis of Design
• Creating a Cleanroom Design
• Creating a Facility Validation Protocol and Reports
• Creating a User Requirement Specification
• Creating Cleanroom Parameters
• Creating EM Sample Sites, Selection and Specifications for Facility Validation
• Design and Validation of Cleanrooms

• Differential Pressure Requirements

• Humidity Requirements
• HVAC Requirements
• Temperature Requirements
• Troubleshooting Facility/Cleanroom Issues
  
  

Quality Control Investigations Consultancy:

• Designing a Corrective Action and Preventative Action (CAPA) Reporting System
• Designing a Departure from QC Procedures
• Designing an Environmental Excursion Investigation Program
• Designing an Invalid Assay Reporting System
• Designing a Laboratory Investigation Reporting System
• Designing an Out of Specification Investigation
• Designing a Sterility Test Failure Investigation Program
  
  

Quality Control and Quality Assurance Auditing Consultancy:

• Performs External Auditing
• Performs Internal Audits
• Performs Vendor Audits and Supplier Qualification
• Prepares a QC Lab for all Regulatory Body Audits
  
  

Technical Writing of all Quality Control (QC) and Quality Assurance (QA) Standard Operating Procedures (SOP):

• Technical Writing of all QC and QA Standard Operating Procedures (SOP)
• Technical Writing of all QC Standard Test Methods (STM’s)
• Updating all QC and QA Procedures to meet different Regulatory Body’s
  Compliance Requirement
  
  

Quality Control Lab Designing and Start-Up:

• Designs and Plans all Quality Control Laboratories
• Performs a Full Quality Control Lab Restructuring and Reorganization
• Performs a Full Quality Control Lab Setup
  
  

Validation Programs Consultancy:

• Cleaning Validation
• Design and Validation of a Barrier Isolator System
• Facility Validation
• Method Validation
• Process Validation
• Validation of MicroSeq Microbial Identification System
• Validation of a New Vitek Compact II System (Protocol and Report writing
  and Execution)
• Validation of all QC Equipment
• Validation of a VHP Sterilization Unit
  
  

Subject Matter Expert for the Following Regulatory Bodies:

• BSi Requirements and Regulations.
• CFR Requirements and Regulations.
• EMEA Requirements and Regulations.
• EU Requirements and Regulations.
• FDA Requirements and Regulations.
• ICH Requirements and Regulations.
• ISO Requirements and Regulations.
• JP Requirements and Regulations.
• MCA Requirements and Regulations.
• TGA Requirements and Regulations.
  
  

Equipment Purchase and Set-Up Consultancy:

• Abbott Quantum IITM Analyzer
• ELISA
• HPLC
• Kinetic LAL Testing- ELX 808 Plate Reader
• MicroSeq DNA Sequencing Equipment
• MilliflexTM
• Sterilizers
• Steritest
• ThinPrepTM 2000 System
• Vitek Compact II
  
  

Compliance Programs Consultancy:

• Provides Consultancy Support for Companies Undergoing FDA Consent
  Decree Remediation
• Provides Consultancy Support for Companies with an FDA Warning Letter
  
  

Quality Assurance Documentation Consultancy:

• Batch Record Review
• CAPA Program
• cGMP Training
• Document Control System
• Employee and Test Method Training Programs
• Investigations, Tracking and Trending
• Product Complaint System and Investigation
• Product Non-conformance
• Product Release
• Quality Engineering
   

Training Programs Consultancy:

• Provides On-Site Training for Company Quality Control Employees
• Webinars on Quality and Compliance Processes and Programs
• Seminars on all Quality and Compliance Processes 

Regulatory Affairs Consultancy

• Regulatory Support and Filing of NDAs, 510K, CMC, IND, ANDA etc)

Give Us a Call   

If you have questions about any of our consulting services, give us a call.