Quality & Process
Outsource your activities, optimize your company’s processes, boost its productivity
Medicinal products and medical devices must be manufactured to ensure that they are fit for their intended use, comply with the requirements of the relevant approved documentation or Authorisation, as appropriate.
They must not place patients at risk due to inadequate safety, quality or efficacy throughout their lifecycle, from the manufacturing plant up to the user’s home. To achieve this objective reliably a Quality system in line with the specific rules of a supply chain is required, and nowadays is particularly complex.
The Quality system has to be comprehensively designed, implemented and constantly improved. Competent and knowledgeable professionals are key to achieve this objectives.
The Quality & Process team, a group of talented experts, is available to cover your needs and meet your goals.
RESEARCH & DEVELOPMENT
Providing you class-leading support in identifying, evaluating and improving product quality and compliance related processes.
- Audits (GLP, GCP, GDP, GMP (IMP, API), GVP, ISO)
- Quality system management (development and start-up)
- Supplier management (Selection, Risk management and audits)
- Quality Documentation & Processes management
- Authority Inspections support (pre and post)
- Remediation plans
- Response to Deficiency Letters
- Risk Management
- Quality by design
- CSV and SW validations
- Validations support (Plants, Processes and cleaning) management and execution
- Data Integrity Management
- Quality related Strategic Advice
MARKETING AUTHORISATION/NOTIFICATION
Offering a constant and continuous quality control throughout the whole production process to ensure that when it comes to placing the product on the market, all the key industry standards are met.
- Quality related Strategic advice
- Quality system services:development, implementation & maintenance
- Validations support (Plants, Production and cleaning Processes)
- CSV and SW validation
- Quality by design
- Documentation management services (SOP, WI, protocols, reports and policies)
- Audits services (GMP, GVP, GDP, ISO)
- Third party audits (GMP part I, Part II, Excipients, Packaging materials etc)
- Authority Inspection support: readiness, deficiency letter management and remediation plans
- Quality Documentation management (drafting, reviewing and compliance assessment (SMF, VMP, CVP, SwVP, CS)
- Mock activities (inspection, recall validations)
- Sterility Assurance management
- Risk Management
- Regulatory updates, follow up and implementation of new requirements (ICHQ3D, Nitrosamine)
- Support for upgrade/updating activities (processes, products, equipments, departments, plants)
POST-AUTHORISATION/MAINTENANCE
Product quality is key for any organization, we are here to help you reach the required level of compliance while tightly optimizing costs.
- Quality related Strategic advice
- Data integrity management (assessment, remediation plans, training)
- Control Strategy services (contamination control, cross contamination control)
- Product and Technology transfer project management, protocol and execution
- Quality Processes (CAPA, Risk assessment, Complaint and Change) management
- Quality review management (PQR and Annual product review)
- Documentation management services (SOP, WI, protocols, reports and policies)
- Audits services (GMP, GVP, GDP, ISO)
- Third party audits (GMP part I, Part II, Excipients, Packaging materials etc)
- Continuous Process Verification
- CMO audit/due diligence
- Continuous Improvement support
- Gap assessment and improvement plans
- Training in house /remote: GXP training, ICH topics training, Refresh trainings, on demand trainings