We are committed delivering high quality solutions for Biotech, Pharmaceutical, Healthcare and Medical Devices that remain cost effective.
We take our 25 years of experience to bring your vision to life. We strive to make your success our business.
CMC
Foundation Solutions GxP offers a full range of CMC support with expertise in both Biologic and Small Molecule Development.
⬡ Representation for our clients with the FDA
⬡ IND, BLA, and NDA Documentation Support
⬡ Establish a Stability Program that meets ICH Regulations
⬡ Support in Development of Biologics, Small Molecules, Devices, and Combination Products
Quality Systems
Foundation Solutions GxP offers a complete range of Quality Systems Support that is tailored to the clients needs while committing to global regulatory expectations.
⬡ Establishment of new quality systems
⬡ Gap Analysis and revision to existing quality systems
⬡ Third party oversight for consent decree remediation
Auditing
Our team has an extensive background to audit your suppliers, manufacturing and laboratory test sites to ensure compliance with current regulations.
⬡ PAI Readiness
⬡ Data Integrity
⬡ GMP, GLP, and GCP Compliance
⬡ Pharmaceutical Quality Systems
⬡ Computer Systems Validation and Part II Compliance
Validation
Foundations Solutions GXP offers an extensive level of experience in establishing and maintaining a compliant validation program for all stages of clinical and commercial operations.
⬡ utility
⬡ facility
⬡ Process
⬡ Cleaning
⬡ equipment
⬡ analytical Methods
⬡ computerized systems
⬡ Analytical Instrumentation
We are committed to providing our clients with a world class level of validation consulting support. Our team has the ability to provide support with the following activities:
⬡ cleaning validation
⬡ computer validation
⬡ validation project management
⬡ commissioning and qualification
⬡ IQ, OQ, PQ generation and execution
⬡ process performance qualification
⬡ microbiological and sterility testing
⬡ cleaning agent effectiveness testing
⬡ validation master planning and gap analysis
Project Management
Our experienced project management team is ready to execute your company's vision and effectively bring it to completion.
⬡ facility expansion
⬡ process improvements
⬡ new facility construction
⬡ new product introduction
training
with 25 years of experience, we can provide your organization with the proper training to help your company maintain compliance with the current industry regulations.
⬡ Annual CGMP employee training
⬡ in house training on regulatory issues/trends