Overview of Select Consulting Engagements

​PharmaLogika has the capacity to support a broad range of expert areas and will accept engagements lasting from hours to years - each client's needs differ dramatically and our flexibility is the key to our success in supporting our clients' success. The following is a brief overview of services completed for a variety of clients:

Third Party Regulatory Compliance Audits (GMP, GCP, ISO, QSR)

Pharmaceutical Companies

Medical Device, Biotechnology & Combination Companies

Contract Research Organizations

Contract Manufacturing Organizations

Third Party Regulatory Compliance Audits (GMP, GCP, ISO, QSR)

​Contracted Facilities and Operations Audits, Multinational

  • FDA PAIs for cGxP with remediation planning and implementation where necessary
  • MHRA / EU inspections for new license applications and follow-on audits with remediation planning and implementation where necessary
  • Multiple and varied regulatory submissions for global agencies
  • SOX 404 compliance review in small cap entities
  • Corporate governance advisory panel appointments and oversight for D&O insurance applications
  • Corporate compensation consultation and package development
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Pharmaceutical Companies

​Mid-size Orals and Topicals Pharmaceutical Manufacturer, Multinational (for Global Operations)

  • ​Quality and Supply Network Remediation
  • Audit and subsequent development of quality and supply network regulatory governance.
  • Audit and subsequent development of supplier certification program.
  • Supplier quality agreement development.
  • Audit and subsequent development of quality assurance product disposition.
  • Training of internal and supplier quality and supply network representatives.

Large Pharmaceutical Company, Multinational (for Global Operations)

  • ​Global Computerized Maintenance Management System (CMMS) implementation
  • Regulatory validation of software development lifecycle (SDLC) pursuant to FDA guidelines in contemplation of 21CFR Part 11.
  • Project management of training development and delivery. 
  • Project management of end-user documentation. 
  • Project management of schedule integration for regulatory systems use conversion.
  • Change management protocol development and implementation.

Large Pharmaceutical Company, Multinational

  • ​Sales and Marketing group regulatory oversight and development
  • Training development and delivery for Regional Sales Directors and District Sales Managers 
  • Regulatory advisor for FDA, HPB, and EMeA-controlled sales and marketing guidelines.
  • Regulatory advisor for product package inserts.
  • Regulatory advisor for doctor and patient education.

Large Pharmaceutical Company,  Multinational (for Global Operations)

  • Implementation of the Integrated Development Training Systemä
  • Regulatory compliance audits and pre-audit inspections
  • FDA liaison
  • Corporate merger integration activities project management
  • Executive feedback and coaching (US operations)
  • Myers-Briggs Type Indicator administration.
  • 360° Feedback facilitator.
  • Balanced Scorecard development and implementation.
  • Succession planning.
  • SAP implementation (US and UK sites)
  • Project management of training development and delivery.
  • Project management of end-user documentation.
  • Project management of schedule integration for regulatory systems use conversion.
  • Six Sigma implementation (Integrated Facilities Management group and Johnson Controls, Inc.)
  • Progression from Total Quality Management.
  • Lean Six Sigma implementation (Global Manufacturing and Production groups)
  • Process facilitator and regulatory advisor.
  • Network Rationalization (US, Canadian, and UK facilities)
  • FDA Form 483 remediation of regulatory training compliance (multiple observations, multiple sites)
  • Asthma Product
  • Investigator’s brochure development.
  • Physician and patient training materials development and delivery.
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​Medical Device, Biotechnology & Combination Companies

Smallcap Biotech Combination Device Manufacturer, Multinational

  • Directed extensive collaboration and liaising with regulatory agencies including the FDA, EMEA, HPB, and MHRA to introduce and request approval for new and enhanced biotechnology / pharmaceutical / medical device and combination products.
  • Introduced an electronic structure filing system to monitor and record clinical trial data, eliminate redundancy, accurately track all activities, provide a training source for new team members, and develop reports for regulatory agencies including SOX 404 compliance.
  • Directed strategic focus for clinical and regulatory efforts to obtain approval for human use of novel combination device and vaccine in SoAm and UAE.
  • Directed clinical and regulatory efforts to obtain clinical approval in the US, Canada, Andean Pact countries and in the central process of the EMEA.
  • Direction and oversight for preparation of domestic and foreign submissions (INDs, NDAs/NDSs, ANDAs, BLAs, NOC/c).
  • Direct liaison with local market health authorities for global interactions both in compliance and submission roles (CBER, DDMAC, BGTD).
  • Directed establishment of hundreds of sponsored research projects at U.S. and foreign universities and contracted research institutions.
  • Design, development, and execution of both global and domestic clinical trials.

​Startup Medical Device  Manufacturer, US Domestic (Global Aspirations)

  • Capital Acquisition > US$15M
  • Sustainable product pipeline development targeting R&D market for assay development
  • SOP development and alignment to serve QSR compliance foundation
  • Operational structure development based on matrixed functions
  • Supplier and CMO contract and network development
  • IP and IPO strategy development
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​Contract Research Organizations

Large Clinical Trials Research Organization, Multinational (for Global Operations)

  • IVR system project management for clinical trial monitoring
  • Regulatory oversight for system integrity.
  • Developed and delivered overview training for 21 CFR Part 11 considerations.
  • Developed financial risk analysis parameters related to regulatory requirements.
  • Program development, implementation, and training.
  • Biostatistics data integration. 
  • Resource loading.
  • Schedule integration.
  • MAPPs implementation.
  • Profit center construction for under-performing global division.
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​Contract Manufacturing Organizations

Large Contract Steriles, Orals and Topicals Manufacturing Organization, Multinational (for US Operations)

  • FDA Warning Letter remediation
  • Creation and submission of remediation progress reports to the FDA
  • Observation catalog development and operational regulatory compliance oversight
  • Corporate Compliance Initiative development, implementation, and management.
  • Project execution plan management
  • Milestone and Project Planning System development, implementation, and management.
  • Regulatory training compliance oversight, development and implementation for cGMP Standards pursuant to the US Code of Federal Regulations, Title 21, Parts 210 and 211(emphasis on §211.25(a-b) and §211.34)
  • Pre-audit inspections of regulatory compliance training systems and design & implementation of compliant training systems.
  • Implementation of the Integrated Development Training System
  • Regulatory compliance audits and pre-audit inspections.
  • FDA liaison.
  • Course development, training, deployment of both CBT and traditional / blended training materials supporting regulatory Quality Systems implementation. 
  • Organizational behavior change management for regulatory compliance
  • Quality Systems (21 CFR Parts 600 and 820) audit and implementation in consideration of FDA guidelines (advisor and project
  • manager).
  • Implementation of validated (21 CFR Part 11) Learning Management Systems (LMS). 
  • Development of standard operating procedures (SOPs) supporting facility and operations regulatory compliance
  • Oversight of regulatory specifications and guidelines.
  • Regulatory operations manuals.
  • Organizational excellence implementation
  • Lean Six Sigma evolution from Total Quality Management.
  • 360° Feedback / Balanced Scorecard administration.
  • Succession planning.
  • Interim executive replacement
  • Director, Regulatory Training.
  • SAP implementation
  • Project management of training development and delivery. 
  • Project management of end-user documentation.
  • Project management of schedule integration for regulatory systems use conversion.

Large Contract Biologics Manufacturing Organization, Multinational (for Canadian Operations)

  • Phase II to Phase III manufacturing facility compliance upgrade
  • Customer observation remediation
  • Observation catalog development and operational regulatory compliance oversight
  • Corporate Compliance Initiative development, implementation, and management.
  • Project execution plan management
  • Milestone and Project Planning System development, implementation, and management.
  • Regulatory training compliance oversight, development and implementation for cGMP Standards pursuant to the US Code of Federal Regulations, Title 21, Parts 210 and 211(emphasis on §211.25(a-b) and §211.34)
  • Pre-audit inspections of regulatory compliance training systems and design & implementation of compliant training systems.
  • Implementation of the Integrated Development Training System
  • Regulatory compliance audits and pre-audit inspections.
  • Customer liaison.
  • Course development, training, deployment of both CBT and traditional / blended training materials supporting regulatory Quality
  • Systems implementation. 
  • Organizational behavior change management for regulatory compliance
  • Quality Systems (21 CFR Parts 600 and 820) audit and implementation in consideration of FDA guidelines (advisor and project manager).
  • Project management of IQ, OQ, and PQ validation 
  • Schedule alignment with production activities and employee scale-backs.
  • Regulatory oversight of training compliance and quality attributes.
  • Documentation control developed and implemented.
  • Implementation of validated (21 CFR Part 11) Learning Management Systems (LMS). 
  • Development of standard operating procedures (SOPs)
  • Oversight of regulatory specifications and guidelines.
  • Regulatory operations manuals.
  • Organizational excellence implementation
  • 360° Feedback / Balanced Scorecard administrator.
  • Succession planning.
  • Interim executive replacement
  • Director, Regulatory Training.
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​Service and Provider Organizations

​Large Accounting and Consulting Services Firm, Multinational

  • Pharmaceutical corporate governance for FDA regulatory requirements related to specific client needs (advisor)
  • Developed and delivered overview training for  21CFR Parts 210-211 and Part 11 considerations
  • Developed financial risk analysis parameters related to regulatory requirements of pharmaceutical clients

​Large Computer Systems Services and Consulting Organization, Multinational (for US Operations)

  • Computer System Validation and Documentation
  • Regulatory validation of software development lifecycle (SDLC) pursuant to FDA guidelines in contemplation of 21CFR Part 11. 
  • Regulatory advisor for system applications in pharmaceutical clinical reporting forms. 
  • Pharmaceutical corporate governance for related FDA regulatory requirements (advisor)
  • Developed and delivered overview training for  21CFR Parts 210-211 and Part 11 considerations

​Large Facilities Management Company,  Multinational (for Global Operations)

  • Operations management and regulatory oversight 
  • Program development, training and project management. 
  • Account Strategy Planning 
  • Business Case Analysis
  • Six Sigma Improvement Team Training 
  • Business Operations Strategy
  • Employee Development
  • Course Development for Subject Matter Experts 
  • Executive feedback and coaching 
  • Myers-Briggs Type Indicator administration.
  • 360° Feedback facilitator.
  • Succession planning.
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​Health Care Providers

​Mid-size Ophthalmic Surgical Clinic, US Regional Operations

  • Regulatory oversight and surgical diagnosis inspections – State-appointed monitor
  • Review surgical records and diagnoses for comparison to patient presentation
 

​Medical School / Affiliated Hospital, US Local Operation

  • Design, development, and delivery of training material for regulatory compliance (FDA, EMeA, OSHA, GLP and CLIA).
  • Emergency care and patient management primer development for non-medical support staff.
  • Organ procurement regulations and guidelines training for first-contact staff. 
  • Patient relations and clinical operations training development.
  • Healthcare and general regulatory medical standards compliance training.
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Petrochemical and Mining Operations

​Large Colliery, US Regional Operations

  • Regulatory compliance oversight
  • Documentation review of EPA, OSHA, and internal SHE requirements.
  • Site inspections for regulatory compliance
  • Regulatory training development and delivery
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