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Quality Services 2017-02-11T15:32:17-05:00

Whether you’re a start-up or running existing operations, our QA experts can help you build or re-engineer your Quality Management System to comply with various regulatory requirements, while maintaining operation excellence and maximizing efficiency.  We provide assistance in writing and developing Quality Manuals including supporting documentation, Quality Policies, Standards and Procedures.  With the “Quality by Design” approach, we help you build and strengthen the foundations of your quality operations.

We provide customized assistance in selecting, qualifying and maintaining a suppliers base that consistently meets or exceeds your requirements.  We perform assessments and site evaluations on your behalf and our certified auditors have significant expertise conducting audits at suppliers of raw materials, active pharmaceutical ingredients and contract manufacturers for both sterile and non-sterile dosage forms. We offer similar expertise in auditing and qualifying medical device manufacturers, analytical service providers and microbiology laboratories. Our team of auditors is fluent in English, French, Spanish, German, Romanian and Arabic and provides multilingual audit reports. We work with suppliers in the Americas, Europe, Africa and the Middle East.

Overwhelmed with deliverables or critical projects nearing deadlines?  Your routine and day-to-day planned activities are falling behind?  Let our experienced QA professionals help you catch-up on your internal audits, assist in executing your validation plan, review your SOPs, or provide technical writing and investigation expertise for your deviations and complaints.  We prepare Annual Product Reviews including summaries, detailed data tabulation and statistical analysis.

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