Regulatory Filings / Submissions
The industry experience of SAVIS, Inc. has enabled our team of engineers and quality experts to be an asset in the certification of any site. Certification of entire facilities and/or areas such as laboratories, waste treatment sites, and stability rooms are essential to most regulated industries. The certification begins with a complete audit of the declared purpose of the site or area. Our qualified team individually identifies and reviews the construction and installation regulations for each site or area, prior to beginning the certification process, then documents and presents any recommendations. Executing a test protocol that demonstrates the site or area conforms to specifications and is acceptable for the intended purpose typically completes the certification process.
cGMP Compliance Audits
Our regulatory experts will review your facility's operations and systems against FDA, EMA, and MHRA regulations. We'll identify any gaps and provide a summary with actionable corrective actions.
Our SAVIS team of quality, operations and engineering support shall address any FDA observations by performing CAPAs and providing long term solutions. We review/revision SOPs, change controls, qualifications, and studies in order to bring all your regulated documentation up to compliance and will work around the clock to provide a swift turn around.