Consulting Services

Whether it is for temporary resource increase on a project or for a specifically required competency, we can provide customized solutions throughout the entire product life cycle.

Our main added values are:

• to have a deep knowledge and understanding of Life Sciences strategic, regulatory and operational challenges, as well as industrial processes, across the entire value chain (R&D, Clinical Trials, Engineering, Production, IS/IT, etc.);
• to provide optimal bundled solutions coupled with implementation strategies, deployment plans and risk mitigation plans;
• to integrate the Regulatory and Quality requirements impacting the Business.

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Aston Project Delivery Model

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Innovation & Business Strategy

Our strength is in our specialization. Because we have built up a deep Life Sciences market and process expertise, we are best positioned to understand our clients’ business challenges, and support them when it comes to Innovation & Business Transformation.

• Identify internal drivers of innovation emerging from our client’s science and technologies
• Undertake market studies and competitive analysis and evaluate portfolio potentials
• Conceptualize new business opportunities and models
• Formalize value propositions based on a differentiating positioning and offering
• Prepare the business case, deploy and carry out the launch strategy and the transformation plan based on an assessment of operational impact
• Bring Engineering and Process solutions to Technology Management and New Product Development (NPD) challenges, including Technology Transfer from R&D to Manufacturing

Regulatory Compliance

We support GxP-regulated companies in the design, implementation, management, evolution and audit of their Regulatory Compliance activities.

• Market entry strategy of Medical Devices (93/42/EC, AIMD, IVD, etc.)
• Submission of Medical Devices (PMA, 510(k), CE marking, ENVISA, JPAL, etc.)
• Market entry strategy of Combination Products (21 CFR 3.2(e))
• Submission of Combination Products (BLA, NDA, PMA)
• Market entry strategy of Pharmaceuticals (FDA, centralized EU, other markets)
• Submission of Pharmaceuticals (INDA, NDA, ANDA)
• Pharmacovigilance, Drug Safety and Post-Market Surveillance
• Dispute Resolution
• FDA-483, Warning Letter, Untitled Letter Response Strategy
  • Recall
  • Audit Non-conformance Response Strategy
  • Acquisition Due Diligence
  • Inspectional Readiness Programs for Inspections and Notified Body Audits
  • Internal Audits

Quality Management

We support GxP-regulated companies in the design, implementation, management, evolution and audit of their Quality Management activities.

• Quality Management System
  • Quality Management System Development / Optimization and Gap Analysis
  • ISO 13485, 21CFR Part 820, ISO 9001, ICH Q7, Q8, Q9 & Q10, 21CFR Part 11, ISO 17025, cGMP
  • Validation & Qualification
• Risk Management and Design Control
  • Design Control, DHF, DMR according to ISO13485/FDA QSR
  • Risk Management (ISO 14971, ICH Q8 and ICH Q9)
  • Risk Analysis / Risk Management methodology (D-FMEA, P-FMEA)
• Human Factors/Usability
  • Human Factors engineering and studies (formative/summative) monitoring
  • ISO 62366
• Quality Management System Auditing
  • Suppliers Auditing
  • QMS Auditing (Internal Audits, Process Audits)
  • Third Party Audit Preparation (Mock Audits)

Information Systems & Digital Transformation

We support R&D, Operations and IS/IT teams to define, build, maintain and support software solutions and infrastructures in the Life Sciences Industry.

• Research & Development (R&D) / Operations
  • High level strategic planning of Business Solutions (Master Plan)
  • Requirement definition, Support to Solutions supplier selection
  • Project Management
  • Computerized System Validation (CSV) according to GAMP5 (Validation Master Plan, Validation Plan, CAPA Risk Analysis, DQ, IQ, OQ, PQ etc…)
• Information Systems (IS) / Information Technology (IT)
  • High level strategic planning of Life Sciences IS/IT solutions (Master Plan)
  • Computer System Validation of Off the Shelf or highly customized Laboratory and Manufacturing Systems as well as ERPs, from Validation lead to scripts/test execution and document writing
  • Project Management: methodology (CMMI, PMP, PM process definition) and operational project management
  • Specialized implementation and development services (ex: Bio informatics, Chemo informatics, LIMS, ELN, EDMS, CTMS, CDMS etc…)

Aston Information System Landscape

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Industrial Process

We can undertake all phases of any Engineering activity: project management, design, construction, commissioning and validation until the hand-over of a complete plant, facility or production line.

• Facilities and Processes
  • Technical Studies, Construction Management, Basic Engineering, Detailed Engineering, Workflow optimization, Resource Planning and Coordination, Cost tracking, Project management, Plant management, Validation
• Equipment (for Manufacturing and R&D Laboratories)
  • Requirement Specification (URS), Functional Design Specification (FDS), Detailed Design Specification (DDS) Procurement (Tender), Workflow optimization, FAT, Commissioning, SAT, Calibration, Metrology, Qualification, Go live, Maintenance, Decommissioning and retirement
• Utilities
  • Requirement Specification (URS), Functional Design Specification (FDS), Detailed Design Specification (DDS), Commissioning and Qualification of Pharmaceutical Water and Steam Systems including HVAC
• Automated systems
  • DCS, SCADA, MES, PLC, etc.
  • User Requirement Specification (URS), Functional Design Specification (FDS), Detailed Design Specification (DDS), Procurement (Tender), Development, FAT, Commissioning, SAT, Qualification, Validation, Go live, Project Management
• Project Engineering
  • Project Infrastructure, Project Organization, Project Management, Value Analysis, Planning, Programming and Monitoring, Design Reviews, Handover
• Methodologies and Tools
  • Project Management Institute (PMI), IPMA, CMMi, GAMP5
  • 6 Sigma, Kaisen, 5S, SMED, 5M, Ishikawa, TPM, Lean Sigma, VSM, Kanban