Our Services

 AUDIT
 SERVICES

Our team of qualified lead auditors has a wide range of experience in all areas of pharmaceutical, medical device and food supplement audits. Our auditors are not only qualified but are field experts who are willing to travel globally to audit your suppliers. We assist our clients to make key decisions on their suppliers based on risk. We help our clients in preparation for regulatory inspections with a range of scenario-based inspection readiness programmes. All of our auditors are IRCA trained to the highest standards and regularly keep up to date with the ever changing regulatory standards.

A few key services in our Auditing arsenal are, but not limited to:

• Active Pharmaceutical Ingredient(API)
• Contract Manufacturing Organisation (CMO) audit
• Data Integrity
• Packaging
• Pre-Inspection Preparation (MHRA/FDA/EMA/ANVISA/ISO)
• Gap Analysis
• Remediation Activity Auditing
• Medical Devices
• GMP/GDP
• Computer System Validation
• Intra Company Auditing
• Preparation & Facilitation of Halal & Kosher Audits

 QUALITY
 MANAGEMENT SERVICES

We have experienced QA professionals who can provide a wide range of support to our clients. We can provide interim QA support, QP/RP, Pharmacovigilance QP & physicians, R&D experts, Technology Transfer & Project Management experts, Method Validation experts, Computer System Validation experts, specialist control system experts and experienced pharmaceutical professionals. We have extensive experience in redesigning quality management systems in line with our clients’ needs and regulatory requirements, to improve client performance.

A few key services in our Quality Systems arsenal are, but not limited to:

• Deviation & CAPA Management & Improvement
• Post-Inspection CAPA Support & Management
• Change Control Process Update & Improvement
• Remediation Support & Management
• Facility Compliance Gap Assessment & Production Advice
• Quality Documentation (SOP, Protocols, Reports, Simplified KPI Generation, etc)
• Risk Assessment
• Self-Inspection Management
• Quality Assurance Support
• EU/UK QP & RP Services
• EU/UK Batch Release
• UK Regulatory Services
• GDP Activities
• Importation Services
• Recall Management
• MIA Application Services

 TECHNICAL &
 REGULARITY SERVICES

Our team has an extensive “hands on” experience in delivering technical projects for our clients. All of our consultants have lived previous working lives within the pharmaceutical, medical devices and food supplements industry and have covered the product life cycle from pre-clinical to post marketing.

A few key services in our Technical arsenal are, but not limited to:

• Serialisation (end to end process)
• Regulatory Support
• Remediation Activities
• Project Management
• Technology Transfer
• Packaging Transfer
• Licensing Support
• Excipient Risk Assessments
• Formulation Development
• Temperature Mapping
• Contamination Control
• Stability Management
• Pharmacovigilence
• Supply Chain Management
• Validation (Process & Equipment Change)
• Facility Design and Equipment Qualification
• Production System
• Packaging and Labelling

 TRAINING
 SERVICES

Our trainers are professionals and industry experts who can generate training packages with real life experience, to ensure that the training is clearly delivered to the trainees. We can create and provide a wide range of training packages that are custom-made to ensure you get the desired benefit. Our trainings are interactive as we use audio, visual & activity based training to impart the necessary knowledge for the trainees, to achieve the desired levels of understanding.

We have spent over £100K in the last couple of years to train our internal team in a world class training environment.

A few key services in our training arsenal are, but not limited to;

• Good Manufacturing Practice (GMP)
• Pharma Quality System (Deviation, Change Control, CAPA Process)
• Good Distribution Practice (GDP)
• Responsible Persons Training
• Regulatory Compliance
• Technology Transfer
• Six-Sigma
• Computer System Validation
• Validation training (Equipment/Process)

 VALIDATION
 SERVICES

Our validation experts have first hand experience in pharamceutical, medical device and food supplement industries and deliver a complete service for our clients. We can generate all validation documentation (VMP, URS, FAT, SAT, DQ, IQ, OQ, PQ, Process Validation, Method Validation, validation report) and perform gap assessment. Our validation engineers can plan, execute, deliver and manage all of your validation needs.

A few key services in our validation arsenal are, but not limited to:

• Validation Master Plan (VMP) Generation
• Computer System Validation (CSV)
• Serialisation
• Validation Risk Assessment
• Data Intergrity
• Cleaning Validation (Cross Contamination Risk Assessment)
• Equipment Validation (Processing & Packing)
• Process Validation
• Method Validation
• Validation Documentation
• Revalidation Strategy.
• Validation Remediation Activities
• Utilities Validation (HVAC, Purified Water, Compressed Air)
• New Facility Qualification