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“We partnered with Kellerman Consulting extremely early on during the SQF certification procedure, and by depending on their knowledge and methodical approach to amassing, compiling, and organizing the required documentation, we were productive in getting our certification.
As your spouse, we can negotiate the potential evaluation minefield of regulatory compliance companies with Perception, hindsight, as well as the apparent advantage of our breadth and depth of data and regulatory compliance consulting. We provide the subsequent pharma consulting regulatory affairs services for pharmaceutical firms.
It’s a pharma consultancy Established by regulatory compliance executives within the pharmaceutical field. Each and every pharmaceutical sector expert over the Regulatory Compliance Associates crew is familiar with the unique inner workings on the regulatory approach.
Qualification of premises, facilities and tools and also the preparing with the corresponding documentation
The definition of the scope to be analyzed is definitely the obligation from the client. In case of comprehensive gap analyses, the GMP/GxP advisor performing the Assessment may well propose clarification of interfaces or transitions concerning unique analyses.
approach were being great. During the audit it gave me self esteem figuring out we experienced every little thing in step with BRCGS requirements.
exceptional diseasecell & gene therapyoncology & hematologydermatologymedtechneurosciencepediatricsanalgesiawomen’s health Foremost just how
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Which has a GMP consultant on board, your Business can concentrate on its core functions even though guaranteeing compliance is meticulously here taken care of.
- We ensure that your plant internet site meets your organization aims though getting fully compliant with the most recent Great Production Exercise restrictions and requirements.
Being an extension of the GMP Auditing crew, we’re capable to carry website out audits on your own behalf, utilizing your proven audit system or perhaps the ADAMAS procedure, whichever functions greatest for your needs.
- 360 degree audit approach To guage the capabilities and good quality devices of suppliers and out-sourcing partners
“They are just down-to-earth true-world men that materialize to get industry experts. We arrived out with a terrific score to keep a major client and our competitive edge with their steerage and expertise”.