Calcott Consulting
Calcott Consulting LLC is a consultancy specializing in the biotech, pharmaceutical, and venture capital industries. They provide expertise in quality management, regulatory guidance, and process validation to help companies navigate complex industry requirements and improve their operations.
Industries
Nr. of Employees
small (1-50)
Calcott Consulting
Berkeley, California, United States, North America
Services
Assess and redesign quality management systems, including document control, lot disposition, CAPA programs and inspection-readiness improvements.
Guidance on implementing GMP practices tailored to clinical and commercial operations, including process controls, packaging and distribution practices.
Develop QbD-based process development strategies and validation plans aligned with current FDA/EMA guidance to establish control strategies and risk-based validation.
Plan and execute abbreviated qualification/verification of compendial and non-compendial analytical methods and support method transfer between laboratories.
Develop vendor qualification programs, performance tracking, and draft quality/technical agreements that allocate responsibilities and audit expectations.
Pre-inspection assessments, mock inspections, development of remediation plans for 483s/warning letters and guidance on meaningful compliance metrics.
Assess and redesign quality management systems, including document control, lot disposition, CAPA programs and inspection-readiness improvements.
Guidance on implementing GMP practices tailored to clinical and commercial operations, including process controls, packaging and distribution practices.
Develop QbD-based process development strategies and validation plans aligned with current FDA/EMA guidance to establish control strategies and risk-based validation.
Plan and execute abbreviated qualification/verification of compendial and non-compendial analytical methods and support method transfer between laboratories.
Develop vendor qualification programs, performance tracking, and draft quality/technical agreements that allocate responsibilities and audit expectations.
Pre-inspection assessments, mock inspections, development of remediation plans for 483s/warning letters and guidance on meaningful compliance metrics.
Expertise Areas
- Quality Management Systems design
- Quality Risk Management (ICH Q9) implementation
- GMP for clinical and commercial manufacturing
- Process validation and Quality by Design
Key Technologies
- Quality Risk Management tools and frameworks
- Process validation frameworks (FDA/EMA-aligned)
- Analytical method qualification and transfer protocols
- Temperature-monitoring and shipment validation techniques
News & Updates
An article discussing the new FDA guidance on remote evaluations, authored by Peter Calcott.
Discussion of the FDA's new position paper aimed at rewarding companies with superior quality programs.
An article exploring the pros and cons of outsourcing SOP writing.
A discussion on implementing effective risk management without overcomplicating the process.
An article explaining the differences and similarities between clinical and commercial GMP requirements.
An overview of the biosimilars market in Europe and the regulatory landscape.
An article discussing the new FDA guidance on remote evaluations, authored by Peter Calcott.
Discussion of the FDA's new position paper aimed at rewarding companies with superior quality programs.
An article exploring the pros and cons of outsourcing SOP writing.
A discussion on implementing effective risk management without overcomplicating the process.
An article explaining the differences and similarities between clinical and commercial GMP requirements.
An overview of the biosimilars market in Europe and the regulatory landscape.