Regulatory Compliance and Quality Oversight

The diverse staff at VeV Scientific is highly cross-trained and has diverse experience in the services offered.  One of these services is ensuring compliance within the organization and helping others achieve the same. Our staff has over 40 years of collective experience in Preapproval Inspections, FDA 483 responses, Compliance Remediation, Site Transfer Protocols, Quality Systems Audits, Regulatory Submissions and various other quality related functions.

VeV Scientific offers the ability to be the third-party quality arm of any organization.  We offer a multiple array of services such as:

  1. cGMP Assessments including GAP Analyses Reports
  2. Documentation Writing:
    1. Validation Protocols (Process Validation or Cleaning Validation)
    2. Standard Operating Procedures (SOPs)
    3. IQs/OQs/PQs (Installation Qualification, Operational Qualification, Performance Qualification)
    4. Batch Records, Deviations, CAPAs, Change Controls
  3. Training Services
  4. Product Complaint Resolutions
  5. On-site Audits in preparation for State and Federal Inspections

Our staff has implemented and validated production lines in Aseptic Processing, Fermentation/Purification/Formulation of Biopharmaceuticals, Medical Devices as well as Oral Solid and Liquid Dose products. We are highly adaptable to the needs of our clients and can easily integrate into any quality system.