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
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.
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
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.
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.
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.
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.
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