Life Sciences
Our support services can help our clients achieve their quality/compliance goals and develop new strategies to optimize their business processes.
Validation & Verification Services
Validation and verification services are critical in the pharmaceutical, biotechnology & medical device industries to ensure that products and processes meet regulatory requirements, are safe, and are effective. Our consulting firm provides a wide range of validation and verification services specifically tailored for the pharmaceutical, biotechnology & medical device industries.
Our R&D support services include:
- Computer System Validation (with regulations (e.g., 21 CFR Part 11) and guidance (e.g., GAMP 5).
- ALCOA++/ Data Integrity Assessments and Remediations
- CSV Assessments and Remediation.
- Process Mapping.
Manufacturing Equipment Support
Manufacturing equipment support is crucial for the pharmaceutical and medical devices industry to ensure the efficiency and quality of manufacturing processes, regulatory compliance, and ultimately, the safety and efficacy of pharmaceutical products. Our consulting firm provides a wide range of manufacturing support services specifically tailored for the pharmaceutical and medical device industry:
- Protocol Development (IQ, OQ, PQ).
- Risk Assessments.
- Facilities/Utilities Qualification.
- Construction Management.
- Project Management.
- Engineering (Design Development, etc).
- Support in Greenfield and Brownfield Expansion Projects.
Quality Control and Laboratory Services
We can help across all areas of QC and Laboratory on both the analytical and microbiological side. We are able to support you from designing a laboratory to supporting the review of your existing quality control processes identifying areas for improvement and implementing strategies to improve quality outcomes.
- Instrument Qualification
- Analytical Method Validation, Method Transfer, Batch Release
- Stability Testing.
- qPCR/ELISA/Flow Cytometry.
- Environmental Monitoring.
- Risk Mitigation.
- Verification of Effectiveness.
R&D Support
Our R&D support services can help our clients achieve their innovation goals and develop strategies to achieve their quality goals. We work with our clients to develop a customized R&D strategy that aligns with their goals and budget. We utilize the latest tools and techniques to help our clients gain a competitive edge and develop innovative solutions that meet the ever-changing regulatory landscape. Our team of experts also offers project management and technical writing services to ensure that our clients can effectively communicate their R&D activities and outcomes to stakeholders. At our consultancy, we are committed to helping our clients achieve success through effective R&D support.
Our R&D support services include:
- Defining Regulatory Goals and Strategy
- Support in Clinical Research
- Establishing QMS and Quality Standards