Clinical Trial Regulatory Compliance & Quality Assurance
Compliance and Quality — The Backbone of Every Successful Trial
At Yashira Consulting Services, LLC, we help sponsors and CROs protect the integrity of their clinical trials through robust regulatory compliance and quality assurance (QA) consulting. With ever-evolving FDA, EMA, and ICH-GCP requirements, trial sponsors must be proactive in maintaining inspection readiness, documentation accuracy, and operational transparency.
Based in the Bronx and serving sponsors nationwide, we bring expert insight into how clinical trials can meet—and exceed—regulatory expectations from study startup to closeout. Our approach ensures that your processes not only follow the rules but are built for efficiency, audit readiness, and ethical rigor.
Why Regulatory Compliance and QA Matter
Clinical trials operate under strict regulatory frameworks, and lapses in compliance can have serious consequences, including:
- Trial delays or suspensions
- Data exclusion or protocol invalidation
- Warning letters or regulatory penalties
- Loss of public or participant trust
Strong quality assurance systems and compliance controls ensure that data is credible, patient rights are protected, and submissions are audit-ready.
Sponsors must also manage multiple stakeholders—from CROs and vendors to site teams and data managers—each with their own risks and responsibilities. That’s where we come in.
Our Regulatory Compliance Services
We provide hands-on consulting to build, assess, and strengthen your regulatory compliance framework.
SOP Development and Documentation
Standard Operating Procedures (SOPs) are essential for consistent, compliant clinical trial execution. We help:
- Develop or revise SOPs specific to study protocols
- Align procedures with FDA, EMA, and ICH-GCP guidelines
- Create document control systems
- Ensure SOPs are practical and reflect actual workflows
- Support SOP training for staff and vendors
Strong SOPs reduce ambiguity, support audits, and establish accountability across your trial operations.
Trial Master File (TMF) and Documentation Oversight
A complete and well-organized TMF is a requirement for compliance. Our support includes:
- TMF setup and index design
- Ongoing document QC and reconciliation
- Missing document tracking and remediation
- File audits for completeness and version control
- Closeout documentation preparation
We help you avoid common TMF gaps that can trigger audit findings or delay submissions.
Regulatory Submission Support
Preparing for a submission or facing regulatory feedback? We offer:
- Regulatory submission planning and document review
- IND and CTA support
- Gap analysis for compliance with agency expectations
- Preparation of responses to FDA or EMA inquiries
- Coordination with regulatory affairs teams
We ensure your submissions are backed by accurate, compliant data and documentation.
Audit Preparation and Inspection Readiness
Inspections and audits are inevitable. We make sure you’re ready with services such as:
- Mock audits based on FDA/EMA frameworks
- Staff interview preparation and role training
- CAPA (Corrective and Preventive Action) planning
- Risk-based monitoring alignment
- Site audit coordination and oversight
With our support, your team will be equipped to respond confidently and accurately to regulatory review.
Our Quality Assurance Services
Quality assurance isn’t just about catching mistakes—it’s about building systems that prevent them.
Quality Management System (QMS) Support
We help sponsors establish or enhance QMS frameworks, including:
- Policy and procedure development
- Quality metrics tracking
- Internal audit planning
- Quality review of trial deliverables
- Root cause analysis and process improvement
We turn quality from a reactive process into a strategic advantage.
Vendor Compliance Oversight
Many quality issues stem from third-party vendors. We ensure oversight by:
- Assessing compliance with study-specific requirements
- Reviewing deliverables for GCP alignment
- Coordinating vendor CAPA implementation
- Supporting documentation from monitoring and data vendors
Your outsourcing model doesn’t have to mean less control.
Our Compliance Consulting Process
We follow a phased approach to build and maintain trial compliance:
- Initial Assessment: We review existing SOPs, documentation systems, and audit history.
- Gap Analysis: We identify deficiencies against regulatory standards and trial-specific needs.
- Remediation Plan: We build a prioritized plan to correct deficiencies and implement improvements.
- Execution Support: We assist with SOP revisions, training, audits, and document QC.
- Sustained Compliance: We offer ongoing support, performance tracking, and inspection preparedness.
This process ensures your trial remains in control, on track, and audit-ready.
Who We Support
Our compliance and QA consulting services are ideal for:
- Biotech startups setting up their first trials
- Pharmaceutical sponsors preparing for audits or inspections
- CROs needing SOP support and QA frameworks
- Academic centers seeking regulatory alignment for investigator-initiated trials
- Sponsors managing complex or multi-site studies
We scale our support to match your needs—whether you're running a single-site study or a global program.
Why Choose Yashira Consulting Services?
- Deep experience with FDA and GCP expectations from industry and academic roles
- Founder-led compliance oversight based on real inspection experience
- Bilingual communication for multinational and community-based trials
- Attention to operational practicality—we design SOPs and QA systems that teams actually use
- Commitment to equity and trust in clinical research execution
We provide the structure, training, and tools you need to protect your data, participants, and trial timelines.
Ensure Your Trial Is Audit-Ready
Don’t leave compliance to chance. Partner with Yashira Consulting Services, LLC for proactive, efficient, and regulatory-aligned quality assurance.