Detailed Technical Consulting and Support:  

Compliance Remediation Services Support or 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)

Contamination Control and Sterility Assurance Support or Consultancy:

  • Aseptic Practices and Programs
    • Cleanroom Personnel Behaviors and Practices Program
    • Personnel, Gowning Practices and Program
  • Cleanroom Trafficking Processes
    • Personnel, Product, Equipment and Waste Flow

Product Release Quality Control (QC)/Microbiology Testing Support or Consultancy:

  • Quality Control Testing Programs:
    • Bacteriostasis and Fungistasis (B & F) 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
    • Various Quality Control Testing Procedures
  • Environmental Monitoring Testing Operations
    • Environmental Monitoring for 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 of a Quality Management Systems
  • Laboratory Information Management System (LIMS) for a Quality Control Laboratory
  • Quality Control Data Management

Cleanroom Utility Program (Water Systems) Support or Consultancy:

  • Design of a New and Modification of Existing Water Systems:
    • Clean steam System

    • Distilled Water System

    • Reverse Osmosis (RO)

    • Water for Injection (WFI)

  • Validation of Water Systems (Protocols, Testing and Reports)
  • Designing Routine Water Testing Programs
  • Validation Guidance for all Water Systems

Cleanroom Utility Program (Gas Systems) Support or Consultancy:

  • Design of a New and Modification of Existing Gas Systems:

    • Argon Gas
    • Compressed Air
    • Nitrogen Gas

  • Validation of Gas Systems (Protocols, Testing and Reports)
  • Designing Routine Gas Testing Programs
  • Validation Guidance for all Gas Systems

Product Stability Program Support or 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 Support or Consultancy:

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

Regulatory Affairs Support or Consultancy:

  • Regulatory Affairs Technical Writing and Review of CMC, IND, NDA Sections

  • Regulatory Affairs New and Existing Product Filing and Support

Sterilization Validation and Routine Testing Support or Consultancy:

  • Biocompatibility Testing

  • E-beam Sterilization

  • Ethylene Oxide Sterilization

  • Steam and Dry Heat Sterilization

  • Vaporized Hydrogen Peroxide (VHP) Sterilization

  • Radiation Sterilization

  • New Medical Device Sterilization Evaluation and Biocompatibility Evaluation

Cleanroom Facility Design and Validation Support or 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 Investigations Support or Consultancy:

  • Corrective Action and Preventative Action (CAPA) Reporting System

  • Departure from QC Procedures

  • Environmental Excursion Investigation and Program

  • Invalid Assay Reporting System

  • Laboratory Investigation Reporting System

  • Out of Specification Investigation

  • Sterility Test Failure Investigations and Programs

  • Deviation Investigations

  • Investigations, Tracking and Trending

  • Product Complaint Investigation

  • Product Non-conformance Investigations

Quality Control and Quality Assurance Auditing Support or 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 Procedures, Methods, Protocols and Reports Support or Consultancy:

  • Technical Writing of all Quality Control (QC) Standard Operating Procedures (SOP)

  • Technical Writing of all Quality Assurance (QA) Procedures

  • Technical Writing of all Quality Control (QC) Standard Test Methods (STM’s)

  • Updating all QC and QA Procedures to meet different Regulatory Body’s
    Compliance Requirement

  • Technical Writing of Validation Protocols and Reports

  • Technical Writing of all Quality Investigations

    • Corrective and Preventative Action (CAPA) Investigations
    • Out of Specification (OOS) Investigation
    • Invalid Assays Investigation
    • Deviation Investigation
    • Environmental Monitoring Investigations

Quality Control Lab Designing and Start-Up Support or Consultancy:

  • 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 Support or 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 2 Compact System

  • Validation of all QC Equipment

  • Validation of a VHP Sterilization Unit

  • Sterilization Validation (Ethylene Oxide, Radiation, Steam, Vaporized Hydrogen Peroxide, E-beam)

Subject Matter Expert for the Following Regulatory Bodies:

  • FDA Requirements and Regulations.

  • BSi Requirements and Regulations.

  • CFR Requirements and Regulations.

  • EMEA Requirements and Regulations.

  • EU Requirements and Regulations.

  • ICH Requirements and Regulations.

  • ISO Requirements and Regulations.

  • JP Requirements and Regulations.

  • MCA Requirements and Regulations.

  • TGA Requirements and Regulations.

  • CFIA Requirements and Regulations.

Equipment Purchase and Set-Up Support or Consultancy:

  • Abbott Quantum IITM Analyzer


  • PCR

  • GC

  • HPLC

  • Kinetic LAL Testing- ELX 808 Plate Reader

  • MicroSeq DNA Sequencing Equipment

  • MilliflexTM

  • Sterilizers

  • Steritest

  • ThinPrepTM 2000 System

  • Vitek Compact II

Compliance Programs Support or Consultancy:

  • Consultancy Support for Companies with FDA’s Form 483 Findings

  • Consultancy Support for Companies with FDA’s Warning Letter

  • Consultancy Support for Companies Undergoing FDA Consent
    Decree Remediation

Quality Assurance Documentation Support or Consultancy:

  • Product Batch Record Review

  • Quality Assurance Product Release

  • Quality on the Floor Support (Quality Engineering)

  • Document Control and Product Test Data Review and Support