Validation Services

Protect your business assets by ensuring a continuous state of validation and regulatory
compliance during future and present operations

483

FDA Compliance

Quality Audits

  • Internal and External Audit support
  • Vendor audit support

Supplemental qualified compliance personnel

  • In-process and product release compliance
  • Consultancy for clients undergoing FDA 483, warning letter or consent decree
  • NDA/ANDA Submission Support
Are you facing an FDA warning letter, form 483 or consent decree?
We Can Help

11

Systems Support

Validation consulting - IQ, OQ, PQ and Process validation per 21 CFR 820, 21 CFR Part 11 and EMEA Annex 15

  • Implementation, operation, qualifications, and final reports for equipment from tablet and liquid dose manufacturing, packaging, and labeling to chemistry and clean labs
  • Factory and Site Acceptance Test protocols
  • Review and remediation of cleaning validation protocols
  • Implementation and qualification of software systems according to FDA code 21 CFR part 11
  • Method validation and transfer support
  • Program process validation

Quality Control

  • Temporary QC technician personnel
  • Analytical Chemist personnel
  • Analytical Microbiological Personnel
  • LIMS admins

503B Compounding Pharmacy Services

  • 483 and Warning Letter Response and Remediation
  • Facility Audit for 503B Compliance
  • Compliance with FDA Compounding Pharmacy Warning Letter Requirements
  • Investigations, Deviations, CAPA Development and Execution

Quality Assurance - Integration of regulatory compliance requirements into existing systems by qualified SME’s

  • Corrective and Preventive Action (CAPA) investigations support
  • Deviation Investigations support
  • Environmental monitoring investigations and remediation support
  • Standard Operating Procedure (SOP) review and technical correction

Project management support for direct and sub-contract scenarios

  • Project scope development by qualified and experienced subject matter experts
  • Project management oversight by experienced Project Managers and SMEs
  • Support for in-scope and unforeseen out-of-scope remediation

Clean Rooms-

  • Environmental Qualification Protocols for Clean Rooms:  
     -Development per FDA and/or EMEA requirements,
      -Protocol Execution and Report Generation,
      -Deviations Management, Investigations and Development of Solutions with Facility Equipment Engineers and Maintenance Personnel
  • Testing and Analysis for Clean Room Contamination Sources and Required Remediation
  • Personnel and Material Movement Analysis
  • Aseptic Practices in the Clean Room Environment

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Training

At LVS we believe in a strong understanding of FDA regulatory compliance and current Good Manufacturing Practices (cGMPs).  In order to meet the training needs of our clients, we have developed relationships with subject matter experts throughout the pharmaceutical consulting industry as well as a mutual partnerships with an additional training firm.  Ask us how we can we can meet your employees’ educational needs.

Contact Us About Training

Integrity and reliability is essential for our industry to build good working relationships and produce quality services. Pharmaceutical industry compliance requirements demand experienced validation professionals who understand the challenges of the pharmaceutical industry and regulatory requirements. It is necessary in our field to know the current regulatory practices that affect developing projects.

We offer creative and effective solutions to address critical issues. It is also essential that projects remain on schedule. LVS employees are a dedicated, reliable team of scientists and pharmaceutical professionals who possess the experience and the technical know-how required to successfully execute projects from product development to commercial production.

LVS is your number one source for professional service. We surpass the competition, not only in price, but in value as well. We can help you protect your business assets by ensuring a continuous state of validation and regulatory compliance.

Aaron Harris, MBA