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We are a professional consulting company founded to help businesses execute management systems based on ISO standards, regulatory requirements and best practices. EM2’s experienced specialists provide comprehensive quality services, from technical writing to process improvements.
From procurement to final release, we provide assurance and control techniques designed to improve our client’s bottom line.
Our goal is to provide simple and practical quality management tools, which help to bring stable and consistent operations to our clients. We strive to meet the needs of our clients through flexible, customized support solutions. We remain focused on the client’s needs, budget, and objectives throughout a project lifecycle. |
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Quality Systems
Quality systems are meant to work in conjunction with business processes, not manage them. We take into consideration what is currently working and build upon that.
• ISO 9001 & ISO 17025
• GMP and GLP
• Custom
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Regulatory
Compliance with government regulations is an essential principle of the healthcare industry. From pharmaceuticals to personal care products, we provide expert assistance on regulatory issues.
• Validation Protocols
• Drug Master Files
• Batch Record Reviews
• IPEC:PQG guildance
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Audits
Audits provide a snapshot of the quality systems of a business. In a short period of time, they can provide a fairly apparent view of how well systems operate.
• Internal
• Supplier
• GMP or GLP
• Gap Assessments
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Laboratory
The key to credible data is a quality management system. Lab data is defendable with concise instructions, well-maintained equipment, knowledgeable employees, and technically sound methods.
• Standard Operating Procedures
• Equipment Qualifications
• Method Validations
• LIMS Administration
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Support Solutions
EM2 can provide on-site support with a customized schedule to fit your business. From biotech start-ups to chemical industry service providers, EM2 can get you on the right track.
• Projects
• Independent QA unit
• Temporary or Long-term QA
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Training
Training and education increase employee morale and provide value-added skills to the workplace.
• Training programs
• Record-keeping
• Custom training classes
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