OUR SERVICES
Auditing
Compliance Remediation
Compliance Remediation
We have a wide range of GxP auditing capabilities including raw material suppliers, API manufacturers, biological and small molecule finished product manufacturers (across a range of dosage forms), storage facilities and wholesale dealers.
Compliance Remediation
Compliance Remediation
Compliance Remediation
If a company finds itself with an inadequate compliance status or is facing regulatory action, Chilford Pharma can help. We have experience of turning around the compliance status of organisations. We provide structured pathways not only to regaining an adequate compliance status, but to integrate compliance as a pillar of the organisation in a sustainable manner. We can correct very costly poor compliance and make full compliance a commercial advantage for your organisation.
Data Integrity
Compliance Remediation
Interim Quality Director / Senior Management Roles
Assuring continual Data Integrity is fundamental to GxP operations. We offer Data Integrity services, providing support to ensure your organisation has compliant and effective Data Integrity by Design systems and processes. We can offer a broad range of Data Integrity services including:
- Data Integrity gap assessments and audits
- Data Integrity compliance remediation
- Generation and implementation of Data Integrity by Design systems, processes and documentation
- Generation of Data Integrity policies and governance procedures
- Generation and implementation of proactive Data Integrity Risk Assessment systems
Interim Quality Director / Senior Management Roles
Interim Quality Director / Senior Management Roles
Interim Quality Director / Senior Management Roles
We have proven experience in providing leadership and strategic direction for the quality function during transition periods. With our experience and expertise in senior level positions within the pharmaceutical industry, we can effect significant change and drive continuous improvement in your organisation..
Lean 6 Sigma
Interim Quality Director / Senior Management Roles
Pharmaceutical Consulting Services
We know that lean and efficient systems and processes lead to enhanced business performance, product safety, quality and efficacy and regulatory compliance. We can assist with:
- Implementing a sustainable lean program
- Process identification and mapping
- Value stream mapping
- Visual Management
- 5S
- Investigation maps
Pharmaceutical Consulting Services
Interim Quality Director / Senior Management Roles
Pharmaceutical Consulting Services
We offer a range of GxP consulting services. Areas of expertise include:
- Cloud IT infrastructure and software
- Company start-ups
- Continued Process Verification / Ongoing Process Verification
- New facility design
- Quality Management Systems
- Quality Target Product Profile (QTPP) and design space establishment
- Risk Management
- Sterility Assurance (including contamination control strategies)
Pharmaceutical Operational Excellence
Pharmaceutical Operational Excellence
Pharmaceutical Operational Excellence
We offer a structured and sustainable Pharmaceutical Operation Excellence (POEx) program that can be tailored to your organisation to increase efficiency, reduce waste and improve quality and compliance.
Qualified Person Services
Pharmaceutical Operational Excellence
Pharmaceutical Operational Excellence
We can provide contract Qualified Person (QP) services for the human pharmaceuticals and animal health industries as defined in 2001/83/EC and 2001/82/EC as amended across a range of dosage forms including sterile small molecule and biologicals products.
Responsible Person Services
Pharmaceutical Operational Excellence
Responsible Person Services
We can provide contract Responsible Person (RP) services for the human pharmaceuticals and animal health industries as defined in 2013/C 343/01.
- MAH holders
- Distributors
- Responsible Person for Importation
- GDP consultancy
Training
Validation
Responsible Person Services
We can offer bespoke training tailored to your specific requirements including:
- Critical Thinking - highly recommended to control unwanted and hidden biases and one of our key foundations for improving efficiency, quality and compliance to drive your business forwards
- GxP training
- Qualified Person sponsorship and support
- Quality Management Systems
- Regulatory updates
- Sterility Assurance and Biological Safety
Validation
Validation
Validation
We can provide GxP validation services such as:
- IT infrastructure qualification (including cloud solutions)
- Computer system validation
- E-QMS selection and validation
- Process Validation (PV/PPQ) support
- Set up of ongoing process verification systems
- Generation of Validation Master Plans and Policies