what we do

Comprehensive Quality & Compliance Services

We help pharmaceutical and life sciences companies meet regulatory requirements, improve operations, and achieve audit success.

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Core Services Overview

What We Do Best

QMS

Site Master File, SMF
Site Quality Manual, SQP
Site Quality Plan, SQP
Site Quality Mgmt. System, SQMS

Expert support and guidance to managing quality system needs.

QMS

Review, Assessment, or development of the following documents:

Standard Operating Procedures (SOP)
Work Instructions (WI)
Processes Documentation Forms (FORM), including
workflow diagrams

Standard Operating Procedure (SOP)

QMS

Document Control Process
Chance Control Process
Investigations/Non-Conformances: NOE, LIR, OOXs, Deviations, CAPAs, EC
Good Documentation Practices (GDP)
Data Integrity (ALCOA++)
Records Retention

Document Control

Training System

Assessment of training curriculum for CTO, CTQ, and CTC site positions
Optimization of training modules and effectiveness checks
Certification and annual requirements
Training Matrix and follow-up
Training Metrics alignment to site KPIs
Tools for control

Develop training matrix
Training System improvement,
Analyst training and certification QC-Lab
Workshop
On-Site training Webinar Standard PPT

Quality Control Laboratory

Mitigate the risk of Data Integrity Incidents by establishing a laboratory-customized system and controls

Review site procedures for alignment with FDA requirements
Align Analyst training modules to GDP and ALCOA requirements
Establish a data review process for HE control and continuous improvement
Develop GDP analyst and team metrics aligned with Laboratory and site KPIs

GAP Assessment
Laboratory Data Review
Method Validation and Transfer
Investigations
Raw Materials Vendor Qualification
Standards and Solutions stability

Remote Services

Writing SOP, WI, Flow Diagrams, and KTA associated as needed
Write or review Laboratory Investigations, Deviations, CAPA, and Effectiveness Check
OOX, NOEs, Deviations, and CAPA Management
QC Laboratory Data Review, Metrics, and Reports
Training System: Assessment, Improvement, Deliver, and Metrics
Auditing: GMP, GLP, Vendor Qualification

Auditing

QC Laboratory Data review
Investigations, Deviation, CAPAs
Writing SOP,
Templates and trackers design

Auditing

GMP Audits
GLP Audits
FDA Readiness Audits
FDA Mock Audits
Supplier Audits

GMP Compliance Audits
Quality System Audits
FDA Readiness Audits
Mock Audits
Audit Partnerships

Tools

SOPs, WI, Webinar, Track&Trend.
SOP, Modules (Basic), Track&Trend

Documents
Templates
Trackers

“Whether you're preparing for an FDA, Remediation, QC Lab Oversight or building QMS from the ground up, we deliver solutions tailored to your needs.”

Let’s Talk. Your First Consultation Is Free.

Ready to strengthen your compliance strategy and improve operations?

what we do

Comprehensive Quality & Compliance Services

Core Services Overview

What We Do Best

QMS

Expert support and guidance to managing quality system needs.

QMS

Standard Operating Procedure (SOP)

QMS

Document Control

Training System

Develop training matrix
Training System improvement,
Analyst training and certification QC-Lab
Workshop
On-Site training Webinar Standard PPT

Quality Control Laboratory

GAP Assessment
Laboratory Data Review
Method Validation and Transfer
Investigations
Raw Materials Vendor Qualification
Standards and Solutions stability

Remote Services

Auditing

QC Laboratory Data review
Investigations, Deviation, CAPAs
Writing SOP,
Templates and trackers design

Auditing

GMP Compliance Audits
Quality System Audits
FDA Readiness Audits
Mock Audits
Audit Partnerships

Tools

Documents
Templates
Trackers

“Whether you're preparing for an FDA, Remediation, QC Lab Oversight or building QMS from the ground up, we deliver solutions tailored to your needs.”

Let’s Talk. Your First Consultation Is Free.

Your Compliance Journey Starts Here

Newsletter Signup

Socials

Quick Links

Info

what we do

Comprehensive Quality & Compliance Services

Core Services Overview

What We Do Best

QMS

Expert support and guidance to managing quality system needs.

QMS

Standard Operating Procedure (SOP)

QMS

Document Control

Training System

Develop training matrix Training System improvement, Analyst training and certification QC-Lab Workshop On-Site training Webinar Standard PPT

Quality Control Laboratory

GAP Assessment Laboratory Data Review Method Validation and Transfer Investigations Raw Materials Vendor Qualification Standards and Solutions stability

Remote Services

Auditing QC Laboratory Data review Investigations, Deviation, CAPAs Writing SOP, Templates and trackers design

Auditing

GMP Compliance Audits Quality System Audits FDA Readiness Audits Mock Audits Audit Partnerships

Tools

Documents Templates Trackers

“Whether you're preparing for an FDA, Remediation, QC Lab Oversight or building QMS from the ground up, we deliver solutions tailored to your needs.”

Let’s Talk. Your First Consultation Is Free.

Your Compliance Journey Starts Here

Newsletter Signup

Socials

Quick Links

Info

Develop training matrix
Training System improvement,
Analyst training and certification QC-Lab
Workshop
On-Site training Webinar Standard PPT

GAP Assessment
Laboratory Data Review
Method Validation and Transfer
Investigations
Raw Materials Vendor Qualification
Standards and Solutions stability

Auditing

QC Laboratory Data review
Investigations, Deviation, CAPAs
Writing SOP,
Templates and trackers design

GMP Compliance Audits
Quality System Audits
FDA Readiness Audits
Mock Audits
Audit Partnerships

Documents
Templates
Trackers