Protecting Product Quality Through Rigorous GMP Audits

Good Manufacturing Practice compliance is the foundation of pharmaceutical product safety and quality. Goldsmith LLC provides thorough, systematic GMP audits that go beyond checklist compliance — we deliver actionable intelligence that strengthens your manufacturing operations and reduces regulatory risk.

Led by Monica Brooks, MSc., our GMP auditing services draw on over two decades of pharmaceutical industry experience, covering finished dose form manufacturers, API producers, contract manufacturers (CMOs/CDMOs), and raw material suppliers.

GMP Audit Services

• Supplier and vendor qualification audits (routine, for-cause, pre-qualification)
• Internal GMP compliance audits and self-inspection programs
• Contract manufacturing organization (CMO/CDMO) audits
• API manufacturer audits per ICH Q7 and 21 CFR Part 210/211
• Pre-approval inspection (PAI) readiness assessments
• For-cause audits following deviations, OOS results, or regulatory concerns
• EU GMP Annex audit support for international operations
• System-based audits across all pharmaceutical quality systems

Key Focus Areas

• Facilities, equipment, and utilities (qualification/validation status)
• Laboratory controls and out-of-specification (OOS) investigations
• Production and process controls, batch record review
• Materials management — receipt, testing, storage, and disposition
• Packaging and labeling controls
• CAPA systems, change control, and deviation management
• Data integrity and 21 CFR Part 11 compliance
• Stability programs and expiry dating compliance

Audit Deliverables

Every GMP audit engagement concludes with a comprehensive written audit report including: executive summary, detailed observations categorized by risk (Critical/Major/Minor), regulatory references, root cause analysis, and a recommended CAPA action plan — all delivered within agreed timelines.

We also provide follow-up support for CAPA implementation tracking, re-audits, and regulatory response preparation as needed.

Ensuring Clinical Trial Integrity and Regulatory Compliance

Clinical research operates in one of the most heavily scrutinized regulatory environments in life sciences. Goldsmith LLC's GCP auditing services provide sponsors, CROs, and academic research organizations with the independent oversight needed to ensure trial integrity, data reliability, and patient protection.

Our GCP audits are conducted in accordance with ICH E6(R2) Good Clinical Practice guidelines, FDA regulations (21 CFR Parts 50, 54, 56, 312), and applicable EU Clinical Trials Regulation — providing you with defensible, comprehensive audit findings.

GCP Audit Services

• Clinical investigator site audits (routine, for-cause, pre-approval)
• Contract research organization (CRO) qualification and oversight audits
• Sponsor quality assurance system audits
• Investigational product (IP) management and accountability audits
• Trial Master File (TMF) completeness and quality reviews
• IRB/IEC and informed consent process audits
• Central laboratory and specialty laboratory audits
• Clinical data management and biostatistics audits

Key Areas of Evaluation

• Protocol adherence and deviation management
• Informed consent processes and documentation
• Subject eligibility, enrollment, and retention practices
• Investigational product storage, dispensing, and accountability
• Safety reporting — AE/SAE identification and reporting timelines
• Data accuracy, completeness, and source document verification
• Regulatory file maintenance and sponsor oversight documentation

Deliverables

All GCP audit reports include: site-specific findings with risk classification, regulatory citation references, sponsor/CRO recommendations, and a CAPA response template to facilitate timely corrective actions and regulatory response preparation.

Navigating the FDA Regulatory Landscape with Confidence

The regulatory pathway from development through approval demands precise strategy, deep regulatory knowledge, and meticulous documentation. Goldsmith LLC provides expert regulatory affairs consulting to guide your product through every stage of the FDA regulatory process.

From early-phase IND strategy to NDA/BLA submission management, post-approval changes, and ongoing regulatory compliance, we serve as a trusted regulatory partner — helping you move critical programs forward with speed and confidence.

Regulatory Affairs Services

• FDA regulatory strategy development and pathway assessment
• IND application preparation, submission, and lifecycle management
• NDA, BLA, and ANDA preparation and submission support
• CMC regulatory support — drug substance and drug product documentation
• FDA meeting preparation and agency communication strategy
• Annual report preparation and regulatory filing management
• Post-approval supplement and variation management (PAS, CBE-30, CBE-0)
• Labeling review, revision, and regulatory compliance assessment
• Regulatory due diligence for business development and M&A

Regulatory Intelligence & Gap Analysis

• Regulatory gap assessments against current FDA guidance documents
• Guidance document tracking and impact analysis
• Competitive intelligence and regulatory landscape analysis
• Warning letter and 483 response strategy and preparation
• Consent decree compliance support

Our Approach

We combine strategic regulatory expertise with practical operational support — ensuring your submissions are scientifically sound, regulatory defensible, and delivered on time. We work as an integrated extension of your regulatory team, bringing senior-level insight to every project.

Quality Systems That Drive Compliance and Business Performance

A robust Quality Management System is the backbone of pharmaceutical regulatory compliance. Whether you are building a QMS from the ground up, remediating an existing system following regulatory observations, or optimizing quality processes for efficiency, Goldsmith LLC delivers practical, compliant quality system solutions.

We understand that quality systems must work for your organization — balancing regulatory rigor with operational practicality. Our approach is collaborative, hands-on, and focused on sustainable compliance.

QMS Services

• Quality management system design, development, and implementation
• QMS gap assessments against 21 CFR Part 211, ICH Q10, and ISO standards
• Standard Operating Procedure (SOP) writing, review, and harmonization
• CAPA system development — root cause analysis, effectiveness checks, trending
• Deviation and non-conformance management system design
• Change control program development and documentation
• Document management system design and optimization
• Product complaints and adverse event reporting system development

QMS Remediation

• Post-inspection QMS remediation following FDA 483 observations or Warning Letters
• Quality system maturity assessments and improvement roadmaps
• Risk-based quality management program development (ICH Q9)
• Annual Product Review (APR) / Product Quality Review (PQR) programs
• Supplier quality management program design

Data Integrity

We specialize in data integrity compliance programs aligned with ALCOA+ principles, FDA guidance, and MHRA expectations — including 21 CFR Part 11 assessments for computerized systems, audit trail reviews, and data integrity gap remediation programs.

Be Ready Before Regulators Arrive

An FDA inspection is one of the highest-stakes events a pharmaceutical or biotech company faces. Whether it's a routine surveillance inspection, a pre-approval inspection (PAI), or a for-cause investigation, your organization's readiness — or lack thereof — has direct business and regulatory consequences.

Goldsmith LLC's inspection readiness consulting helps pharmaceutical, biotech, and life science organizations identify and address compliance vulnerabilities proactively, prepare teams to respond confidently during inspections, and build sustainable quality systems that withstand regulatory scrutiny.

Inspection Readiness Services

• Comprehensive inspection readiness gap assessments
• Mock FDA inspections — GMP, GCP, GLP, and pre-approval (PAI)
• Facility walk-through assessments with a regulatory perspective
• Front room and back room strategy development and role assignments
• Inspection preparation training for senior leadership and site teams
• Document retrieval and pre-inspection organization support
• Observation response and CAPA development — 483 and Warning Letter responses
• Post-inspection support and commitment follow-through tracking

Mock Inspection Program

Our mock inspections are structured to closely simulate actual FDA inspection methodology — including documentation requests, facility tours, personnel interviews, and record reviews. Findings are delivered in an FDA-style 483 format, giving your team a realistic experience and a clear remediation roadmap.

483 & Warning Letter Response

• Strategic review and prioritization of observations by risk and complexity
• Root cause analysis facilitation for each observation
• CAPA development with realistic timelines and measurable outcomes
• Response document drafting — technically sound, regulatory defensible
• Follow-up monitoring and commitment tracking

Building a Culture of Quality Through Expert GxP Training

Compliance is only as strong as the people who execute it. Goldsmith LLC designs and delivers targeted GxP training programs that go beyond regulatory recitation — building genuine understanding, practical competency, and a lasting quality mindset across your organization.

Our training programs are fully customized to your company's systems, procedures, products, and regulatory environment. Whether onboarding new staff, conducting annual GxP refresher training, or addressing a specific compliance gap, we deliver training that makes a measurable difference.

Training Programs Available

• GMP fundamentals and advanced GMP for pharmaceutical manufacturing
• GCP principles and clinical trial conduct for sponsors, CROs, and site staff
• GLP compliance training for laboratory professionals
• Data integrity and ALCOA+ principles — practical implementation training
• 21 CFR Part 11 and computerized system compliance training
• Deviation, CAPA, and root cause analysis techniques
• FDA inspection awareness and inspection behavior training
• Quality risk management — ICH Q9 concepts and application

Training Delivery Formats

• On-site instructor-led training workshops and seminars
• Virtual instructor-led training (VILT) sessions
• Management and leadership training for quality executives
• New hire onboarding GxP training modules
• Targeted remediation training following inspection findings
• Training effectiveness assessments and competency evaluations

Custom Curriculum Development

We develop complete, company-specific GxP training curricula including training materials, presentations, exercises, quizzes, and competency assessments — all tailored to your SOPs, products, regulatory filings, and workforce. Training documentation is provided to support your training records requirements.