Global Operations Management

More than ever, biopharmaceutical and medical device companies are facing new operational challenges as they attempt to produce products efficiently in an increasingly complex global environment. 

Reduced internal resources, as well as the dynamic marketplace, dictate the need for experienced, strategic partners that possess both the skills and the resources required to supplement your internal capabilities.  Possessing experience in unique areas such as biologics and controlled substances, CRL works  with and supports a varied client base, including a wide range of Pharma and Bio-pharma companies, helping them to develop innovative solutions to challenging issues.

Services offered:

• Good Clinical Practice (GCP) / Good Manufacturing Practice (GMP) strategy development and implementation
• Manufacturing compliance and audits, including GCP, GMP and Performance Audit Inspection (PAI) readiness, as well as pre and post audit support
• Strategic third party or supplier audits and assessments to improve performance and manage risks associated with product safety, production delays, and systems failures
• Distribution and Customer Service risk and opportunity assessments
• Compliance Governance Assessments and the development/refinement of relevant processes, procedures, and methods
• Health, Safety and Environmental reviews
• Manufacturing and Supply IT support; support of legal counsel in regulatory enforcement matters (US and EU)
• Preparation of responses to FDA manufacturing inspectional observations (FDA 483's) and warning letters
• Operational profitability improvement assessments
• Human capital analysis and development, including leadership evaluation and teamwork development.

Reduced internal resources, as well as the dynamic marketplace, dictate the need for experienced, strategic partners that possess both the skills and the resources required to supplement your internal capabilities. Core Risks Ltd. has the resources to support both your strategic and practical operational requirements.  We are a globally experienced team, led by the former Vice President of Operations of a major pharmaceutical company. Our unique understanding and sensitivity to cultural and regulatory matters allowing to better help you solve challenging obstacles to success. We have developed streamlined organizations devoted to regulatory, quality control, analytical chemistry, and tech transfer issues, and can provide business oriented solutions which balance compliance, risk and company needs.

CRL can add value at all stages of your company's development, from start up planning through production trouble shooting and solutions development and implementation.