About Us
Transforming Research-stage Companies into GxP-Compliant Industry Leaders
We are Pharmaceutical & Biotechnology GxP Quality Unit (QU) Subject Matter Experts (SME) professionals with over 34 years of industry experience, specializing in small molecules, large molecule biologicals, and peptides. We have a proven track record of working in site and corporate roles across the US, EU, and Asia.
- Develop, implement, and manage a comprehensive Quality Management System (QMS) and Regulatory Filing model.
- Ensure compliance with current international GxP regulations throughout the product life cycle.
- Tailor Quality Control (QC) and Quality Assurance (QA) efforts based on product phase and company focus.
- Foster a knowledgeable and focused Quality Unit (QU) team through training and development.
Services
Our Services
Documentation
Our services encompass creating and maintaining SOPs, policies, quality manuals, protocols, reports, and MBRs to ensure compliance with GXP regulations and promote consistency and adherence to industry standards.
Read MoreOrganizational Structures
We assist in defining, establishing, and evaluating organizational structures, roles, and responsibilities, including sponsors, QU (QA and QC), executive management, and CMC teams, aligning with GxP regulations and guidelines.
Read MoreQuality Management
We provide comprehensive support in establishing, documenting infrastructure, evaluating, and performing quality management processes. This includes implementing an EDMS, supporting regulatory filings, managing Change Control and Change Management, and offering staff qualification and training services.
Read MoreService Providers
Our expertise extends to selecting, conducting due diligence, qualifying, and monitoring service providers, including vendors, CROs, CMOs, CTOs, and contract development organizations, ensuring compliance with GLP, GCLP, GCP, GMP, and analytical and process studies.
Read MoreNon-conformance and CAPAs
We recognize the criticality of addressing non-conformance events promptly. Our services include identifying root causes, implementing corrective actions, and establishing preventive measures through effective CAPA management to ensure continuous improvement and regulatory compliance.
Read MoreProduct Management
Our offerings cover the comprehensive Review and Monitoring, evaluation, and management of products throughout their lifecycle. This includes reviewing BPCRs, ensuring product quality and compliance, managing lot disposition, updating IBs, and overseeing manufacturing, packaging, labeling, and coding of investigational products.
Read MoreReady to elevate your GxP compliance? Contact us today!
Open your full GxP potential by partnering with us. Our expert team can help elevate your compliance standards to new heights. Don’t wait. Contact us today and take the first step towards achieving regulatory excellence.
Founder Of GxP Council
Jamie Jamshidi
Jamie Jamshidi is a Quality Unit (QU) and Regulatory Operations (RO) professional with over 34 years of industry experience, including small molecules, large molecule biologicals and peptides. Jamie experience gained working in the US, EU & Asia in site and corporate roles. Jamie has held leadership roles in Quality Unit (QU) and Regulatory Operations (RO) throughout product lifecycle.
