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 promptly supplement your internal capabilities. CRL can help.
Led by the former Vice President of Operations of a major pharmaceutical company, CRL’s experts support a variety of clients, from emerging to large life science companies and have experience in unique areas such as biologics and controlled substances.
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. CRL has the resources to support both your strategic, as well as your practical operational requirements.
Services we provide:
- GCP/GMP strategy development and implementation
- Manufacturing compliance and audits, including GCP, GMP and PAI inspection 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
- Health, Safety and Environment assessment and 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