GxP Base
Pharma | Devices | Biotech
Our Work is Quality.
GxP Base is a premier consulting group specializing in building, supporting and remediating GMP and GLP Quality Systems. We have over 50 years combined experience in regulated industry, working with pharmaceutical, medical device and biotechnology companies in the USA and abroad.
Our Services
Quality Systems Development
Auditing and Supplier Qualification
Inspection Preparation and Remediation
We specialize in developing, supporting and improving quality systems for startups, virtuals, and established companies. Our approach is pragmatic and right-sized for your organization - we don't use cookie cutter SOPs and work with your team to implement compliant and efficient processes.
We perform dozens of audits per year of raw material and component suppliers, CMOs, drug-depots and more. We have an extensive database of audit reports and can help you with initial supplier qualification, routine or technical audit. We have an efficient remote audit program to meet your compliance needs during the COVID-19 travel restrictions.
Preparing for an FDA or foreign regulatory agency inspection requires experience and a proper strategy, We have helped many drug and device companies in the US and abroad successfully get through their PAI, routine or for-cause inspections. We understand current inspection trends and can assess and enhance your company's inspection readiness.
The Team
Chirag Asaravala
Consultant
CQA, CSQE
Chirag held positions as Director of Quality, Director of Corporate Compliance and Compliance Officer at Chiron and Tethys Bioscience prior to full-time consulting. His background spans diagnostics, medical devices, software, small molecule drugs, biologics, and more recently gene-editing technologies.
Chirag graduated from Cal Poly San Luis Obispo with a B.S. in Biology and has an M.B.A from St. Mary's College of California.
Featured Work
Technology
Company
Our Role
Anti-microbial therapeutics for multi-drug resistant (MDR) bacteria.
In clinical trials.
cGMP quality systems development; quality management consulting
Alzheimers & Parkinsons therapeutics.
In clinical trials.
cGMP quality systems development; CMO qualification / auditing
Nanoparticle drug delivery system for peanut allergy immunotherapy.
Clinical trial pending.
cGMP quality systems development; quality management consulting
South Korea based CMO for Sagent Pharma biosimilar drug API manufacturing.
cGMP quality systems development; quality management consulting; aseptic process optimization; FDA PAI readiness.
CRISPR-Cas9 gene-editing for cancer therapeutic.
Clinical trial pending.
cGMP quality systems development; CMO qualification
CRISPR-Cas9 gene-editing in hematopoietic stem cells for sickle-cell disease.
CMO qualification / auditing
CRISPR-Cas9 based anti-viral.
(Company acquired by Vir Biotechnology)
cGMP quality systems development; CMO qualification
Pathogen inactivation in blood transfusion products.
US and exUS commercial products.
Design control / design history file auditing; internal audit and FDA MSDAP inspection prep.
Artificial intelligence and iPhone/iPad based medical devices for surgical blood loss monitoring.
Design control / design history file auditing; internal audit support.
Artificial intelligence and iPhone/iPad based medical devices for surgical blood loss monitoring.
Design control / design history file auditing; internal audit support.
South Korea based vaccine manufacturing
cGMP quality systems; aseptic processing remediation; FDA / MHRA inspection readiness.
Contact
Stephen S. Burr
Consultant
Steve's expertise is facilities, utilities and process validation. His industry positions begin at Cutter/Bayer in the 1970's and lead to Director of Validation for Chiron/Novartis. His consulting work focuses on design, implementation and validation of cleaning and sterilization programs, aseptic filling processes, and lyophilization. Steve routinely authors CMC sections for US and EU regulatory applications.
Steve attended the University of California Berkeley.