O: Paul O'Neill

BPharm MA MRPharmS MCMI MTOPRA

PGO Consultancy Services

Established in 1994, PGO Consultacy Services provides Regulatory Affairs services specialising in the Quality/ CMC aspects of human and veterinary product licensing, including biotechnology products, vaccines, oral, topical, implanted and parenteral products. Specific services offered include:
· Compilation of Module 3: Quality/ CMC Dossiers (previously Part II)
· Quality Overall Summaries for CTD, Module 2.3 (previously Part ICI)
· Compilation of Module 3: Quality/ CMC Dossiers
· Compilation of Certificate of Suitability (CoS/ CEP) dossiers
· Compilation of European Drug Master Files (EDMF/ ASMF)
· Generation of a cohesive approach in the Quality Module and development programmes
Paul has extensive experience in many European countries, and his clients have included Japanese and US companies.

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Areas of expertise:

• Advanced Food Hygiene Certificate
• Advertising
• Agglomeration technologies
• Analytical characterisation
• Analytical method development and validation
• API manufacture
• Auditor: British Retail Consortium (BRC) GS - Food
• Biocides
• Biotechnology
• Borderline product issues (biocides, drug+device)
• Business analysis from Profit & Loss and Balance Sheet data
• Business cost analysis
• Business development
• Business development and optimisation
• Business plans / analysis
• Business start up
• Carbohydrate chemistry
• CE marking
• Chemical process costings
• Chemistry, manufacturing and controls
• Chewing gum manufacture
• Chilled foods
• Chocolate
• Chocolate and cocoa technology
• Clinical and health
• Clinical nutrition
• Clinical research
• Clinical study project management
• Clinical trial applications (EU, USA, Canada)
• CMC
• Colloid & interface science
• Communications strategy development
• Confectionery
• Contractor management
• Cooked meats
• Corporate finance
• Corporate image development
• CoS CEP Certificates of Suitability
• Crisis Management
• Cryogenic spray crystallisation
• Development Food Ingredients
• Diagnostics
• Diet and health
• Drug development
• Due diligence
• Environmental technology
• Event organisation
• Experimental design
• Expert reports (safety, quality, efficacy)
• Expert summaries
• Expert Witness
• Export certificates (CPPs)
• Factory audit
• Factory commissioning
• Factory equipment specification
• Factory layout and design
• FDA NDAs
• Feed additives and ingredients
• Fertilisers
• Food
• Food additives and ingredients
• Food anaylsis
• Food and food ingredients
• Food casings
• Food chemistry
• Food composition and analysis
• Food hygiene
• Food ingredients
• Food quality systems (meat)
• Food regulations
• Food safety
• Food science
• Food science and technology projects
• Functional polysaccharides
• Gels, thickeners & stabilisers
• General management
• Generics
• Glass transitions
• Glycobiology
• Glycosylation
• GMP auditing
• Good Manufacturing Practice (GMP)
• HACCP systems
• High potency sweeteners
• Human and veterinary medicines
• Identification of skills requirements and training
• Information management
• Information sourcing
• Ingredient innovation
• Innovation workshops
• Intense sweeteners
• Interim Management
• International presentations on EU food chain laws
• Investigational Medicinal Product Dossiers (IMPDs)
• ISO 9001:2000 as Lead Auditor/Third Party
• Literature search
• Low calorie sweeteners
• Management seminars and training
• Manufacture Food Ingredients
• Manufacturing support
• Marine ingredients
• Market assessment
• Market Development
• Market research
• Marketing and strategy development
• Marketing authorisation applications (MAAs)
• Marketing communications
• Meat and meat products
• Meat comminution and mechanical handling
• Meat drying and fermentation
• Meat processing technology
• Meat smoking and curing
• Medical devices
• Medical writing
• Microbiological standards
• Model fitting
• Monitoring
• New product development
• New product ideas
• New technology commercialisation
• Non-parametric tests
• Non-sterile products
• Nutrition
• Obtention of EU approvals for food chain products
• Operations development
• Organic Chemistry
• Orphan medicinal products
• Parenteral products
• Permutation tests
• Pesticides
• Pharmaceuticals
• Pharmaceuticals
• Pharmaceuticals (veterinary)
• Pharmacokinetics
• Phase I studies
• Phase II studies
• Phase III studies
• Phases I-IV
• Physical chemistry
• Physical testing
• Physiological response to foods
• Pre-clinical studies
• Preparation of Quality Modules
• Press & public relations
• Process and product innovation
• Process and product technical problem-solving
• Process audit
• Process control
• Process design
• Process development
• Process development and control
• Process innovation
• Product development
• Product formulation
• Product launch
• Product traceability
• Project management
• Project planning
• Publicity and PR
• QT prolongation
• Quality assurance
• Quality Audit
• Quality control and management
• Quality modules of CTD - 2.3 and 3
• Quality Systems
• Quality Systems to ISO and BRC Certification
• R&D strategy and development
• Randomisation/Randomization
• Regulatory
• Regulatory affairs
• Regulatory and environmental
• Regulatory issues - quality
• Research management
• Review of documentation
• Rheology
• Rubbery states
• Sales
• Sample size determination
• Sausage
• Sensory analysis
• Simulation
• Specialist blending
• Spray drying
• Statistical analysis
• Statistical experiment design
• Statistical report writing
• Statistical Training
• Statistics
• Strategic marketing planning
• Study reports
• Sugar confectionery technology
• Sugar-free confectionery technology
• Supply chain operations
• Taste testing
• Technical and Market research
• Technical Information development
• Technical presentation
• Technical writing
• Technical, copy and 'ghost' writing
• Technology audit
• Technology transfer
• Training
• Training courses
• Training in effective writing
• Training in presentation skills
• Vaccines
• Variations, renewals, SPC and Labelling issues
• Veterinary Pathology
• Veterinary pharmaceutical products
• Virtual companies
• Waste treatment