Comprehensive GxP Services

Our Services &
Solutions

From GxP audits and regulatory compliance to software development — every service is tailored to your regulatory landscape and delivered with precision.

GxP Audits Documentation Validation EU Inspections PIC/S Inspections Training Software Clinical MA Holding Turnkey projects Technology Transfer service Warehousing services in EU, Ukraine

Service 01

GxP Audits &
Supply Chain

Rigorous GxP compliance auditing across GMP, GCP, GLP, and GDP frameworks — covering every product category in your supply chain, giving regulators and stakeholders full confidence in your operations.

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Products We Audit

💊Medicinal products — sterile & non-sterile

🧪API & API intermediates — sterile & non-sterile

🔬Contract testing laboratories

🚚Distributors — GDP

📦Packaging materials

🧬Biological & cosmetic products

⚗️Excipients, KSMs & raw materials

Our Audit Process

7-Step Quality GMP Auditing Process

Pre-Audit Preparation

Thorough review of existing documentation, regulatory history, and identification of key compliance risk areas before the audit commences.

Audit Arrangement

Coordinating logistics, scheduling interviews with key personnel, and establishing the audit plan and scope with all stakeholders.

Conducting the Audit

On-site/remote systematic evaluation of GxP compliance — inspecting facilities, processes, documentation, and personnel practices.

Audit Reporting

Preliminary comments delivered within 1 week. Comprehensive audit report with findings and risk classifications within 4–5 weeks.

CAPA & Compliance Follow-up

Active monitoring and guidance through Corrective and Preventive Action implementation until all findings are formally closed.

Audit Closure

Formal closure of all audit findings with verified evidence. Issuance of official audit closure certificate.

Follow-up Audits

Scheduled re-audit every 3 years to ensure continued compliance and ongoing improvement of your GxP systems.

Service 02

GxP Documentation
Preparation

We write, review, and optimize your pharmaceutical documentation from scratch — ensuring compliance with WHO, FDA, EMA, and ANVISA regulations and preparing you for any audit or inspection.

✓ Writing documents from scratch
✓ Reviewing & improving existing SOPs
✓ Ensuring regulatory compliance (WHO, FDA, EMA, ANVISA)
✓ Tailored for your product type & target market

Documentation Services

Every Document
Audit-Ready

Quality Management System (QMS) Documents
Standard Operating Procedures (SOPs)
Production & Batch Records
Quality Control Documents
Regulatory & Compliance Documents
Training & Personnel Documents
Facility & Engineering Documents

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Quality Management System

Quality Manual

Quality Policy

Site Master File (SMF)

Validation Master Plan (VMP)

Full QMS build from zero if needed

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SOPs

Equipment Cleaning SOP

Batch Manufacturing SOP

Deviation Handling SOP

Change Control SOP

CAPA SOP

Complaint Handling SOP

Recall and Mock recall SOP

Data traceability and integrity

Validations and Qualifications

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Production & Batch Documents

Batch Manufacturing Record (BMR)

Batch Packaging Record (BPR)

Master Formula Record (MFR)

Equipment & Temperature Logbooks

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Quality Control Documents

Specifications (RM & Finished Product)

Analytical Methods

Method Validation Reports

Stability Study Protocols & Reports

Certificate of Analysis (CoA) Formats

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Regulatory & Compliance

Dossier Preparation (CTD / eCTD)

GMP Audit Reports

Risk Assessments (ICH Q9)

Data Integrity Documentation

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Facility & Engineering

HVAC Qualification Documents

Water System Validation

Environmental Monitoring Procedures

Calibration Records

Service 03

Validation &
Qualification

We provide complete validation and qualification lifecycle support — from protocol development through execution and reporting — ensuring your equipment, processes, and systems meet all GxP requirements.

IQ · OQ · PQ

Full qualification lifecycle support from installation through performance — with rigorous documentation for every step.

Process

Validation

Cleaning

Validation

CSV

Computer Systems

Full

Documentation

Installation Qualification

Equipment & System Installation

Documented verification that equipment is installed correctly according to manufacturer specifications and regulatory requirements — the critical first step.

Operational Qualification

Functionality & Operating Limits

Verification that equipment operates within defined parameters across its entire operating range — ensuring consistent and reliable performance.

Performance Qualification

Real-World Process Performance

Confirmation that equipment consistently produces results meeting predetermined acceptance criteria under actual production conditions.

Process Validation

Protocols & Comprehensive Reports

End-to-end process validation covering all stages — concurrent, prospective, and retrospective — with full protocol development and execution reporting.

Cleaning Validation

Cross-Contamination Prevention

Scientific evidence that cleaning procedures effectively remove product residues, degradation products, and microbial contamination to acceptable limits.

CSV

Computer System Validation

21 CFR Part 11 / Annex 11

Full lifecycle validation of computerized systems — from user requirements through qualification and ongoing periodic review — ensuring data integrity compliance.

CSV

Service 04

EU Inspection
Readiness &
Compliance

Elixir GxP Solutions — your first choice EU GMP compliance partner for manufacturers in the Asian region, offering comprehensive in-house services that ensure a well-planned pathway towards EU market access.

"Our experienced consultants will train and lead your team towards successful EU GMP certification — creating a GMP culture and mindset that leaves auditors in no doubt of your readiness."

Start EU Compliance Journey →

Our Approach

EU GMP Compliance in 5 Phases

EU GMP Reviews & Gap Analysis

Comprehensive assessment of current systems against EU GMP requirements, identifying gaps and prioritizing remediation actions.

EU GMP Audit Preparation

Aligning facility documentation and processes with EU GMP regulations and guidelines. Intensive team training and readiness coaching.

Pre-Inspection Audit by EU Partner

European-based third-party EU GMP auditor provides thorough facility assessment before the official regulators arrive.

Application Submission to EU Authorities

Expert guidance through the formal application process — ensuring all submissions are complete, accurate, and compliant.

Final Liaison with EU Authorities

Acting as your expert liaison during regulatory review — managing queries, follow-ups, and ensuring a right-first-time outcome.

Service 05

PIC/S Inspection
Readiness

Elixir GxP Solutions — your first choice PIC/S compliance partner. We offer comprehensive in-house PIC/S compliance services ensuring a well-planned pathway towards market access.

🇺🇦 Specialising in Ukraine PIC/S Inspections

Get PIC/S Consultation →

5-Phase Approach

PIC/S Compliance
Framework

PIC/S Reviews & Gap Analysis

Comprehensive evaluation of your facility's compliance gap against PIC/S requirements with targeted remediation planning.

PIC/S Audit Preparation

Systematic preparation of documentation, processes, and personnel — building genuine GMP readiness culture throughout your organization.

Pre-Inspection Audit by PIC/S Partner

Our PIC/S partner conducts a thorough mock inspection to identify remaining gaps before regulators arrive.

Application Submission to PIC/S Authorities

End-to-end support through the formal PIC/S application and submission process.

Final Liaison with PIC/S Authorities

Expert representation and liaison management throughout the regulatory review to achieve a right-first-time outcome.

Service 06

GMP Trainings

Equip your team with the GxP knowledge and practical skills needed to maintain compliance excellence — from foundational GMP principles to advanced regulatory topics.

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Foundational GMP Training

Core GMP principles, regulatory expectations, and compliance fundamentals for all levels of your organization — manufacturing, QA, QC, and management.

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Documentation & Data Integrity

Best practices for GDP (Good Documentation Practice), ALCOA+ principles, and ensuring data integrity across all GxP records and systems.

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Internal Audit Training

Hands-on training for internal auditors — covering audit planning, execution techniques, finding classification, and effective CAPA management.

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Risk Management (ICH Q9)

Practical risk assessment methodologies — FMEA, HACCP, risk ranking — aligned with ICH Q9 and integrated into your quality management processes.

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Regulatory Intelligence

Navigating FDA, EMA, ICH, WHO, and PIC/S regulatory frameworks — understanding requirements, trends, and their practical implications for your operations.

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Computer System & CSV Training

Understanding 21 CFR Part 11, Annex 11, and computer system validation requirements for GxP-regulated computerized systems.

Service 07

GxP Software
Development

Purpose-built software solutions for life science organizations — designed with GxP compliance at their core, not bolted on afterward.

eQMS

Electronic Quality Management System

Quality Management, Digitized

A fully electronic, audit-trail-enabled QMS platform covering deviations, CAPAs, change control, document management, training records, and complaints — all in one compliant system.

21 CFR Part 11 Annex 11 Audit Trail e-Signatures

eDMS

Electronic Document Management System

Document Control at Scale

Controlled document lifecycle management — version control, review and approval workflows, distribution tracking, and compliant archiving. Ensure the right documents reach the right people, always.

Version Control Workflows Access Control GxP Validated

WMS

Warehouse Management System

GxP Warehouse Intelligence

GDP-compliant warehouse management covering inventory control, quarantine management, FIFO/FEFO, temperature monitoring, goods receipt, dispatch, and full traceability from receipt to release.

GDP Compliant Traceability FIFO/FEFO Temperature Log

LIMS

Laboratory Information Management System

Lab Data, Fully Controlled

End-to-end laboratory data management — sample management, test scheduling, results capture, OOS/OOT handling, stability studies, instrument interfacing, and compliant reporting. GLP and GMP ready.

GLP/GMP OOS/OOT Stability Instrument Interface

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Service 08

Clinical Study
Support

A clinical study of medicinal products is a scientific investigation carried out in humans to evaluate the safety, effectiveness, and behavior of a medicine — a key part of drug development ensuring a product works as intended.

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Safety

What side effects or risks the medicine may cause

✅

Efficacy

How well the medicine treats or prevents disease

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Dosage

What dose works best with minimal risk

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Pharmacokinetics

How the body absorbs, distributes, and eliminates the drug

Study Design

4 Phases of Clinical Studies

Phase I — Safety & Dosage

Small group of healthy volunteers or patients to assess initial safety and optimal dosage range.

Phase II — Effectiveness

Larger group to evaluate therapeutic effectiveness and gather further safety data.

III

Phase III — Large-Scale Trials

Large-scale confirmation of effectiveness, side effect monitoring, and comparison with standard treatments.

Phase IV — Post-Marketing

Studies conducted after approval to monitor long-term effects and real-world safety data.

Service 09

MA Holding &
Regulatory Services

MA Holding and all required Regulatory Affairs, Pharmacovigilance, Qualified Person services in Europe, Ukraine & CIS countries — with GDP warehousing in EU-GMP / PIC/S approved facilities.

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Regulatory Affairs

Marketing authorization applications
CTD/eCTD dossier preparation
Variation submissions
Regulatory strategy
GMP compliance support

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Pharmacovigilance

Adverse event reporting
EU-QPPV services
PSMF maintenance
Signal detection
Safety database management

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Qualified Person

Batch release certification
GMP oversight
Import certification
Audit and compliance support

Service 10

Warehousing
Services

GDP warehousing in EU-GMP and PIC/S approved facilities across the EU, Ukraine, and Uzbekistan — providing full-service pharmaceutical logistics and storage.

🇪🇺 European Union

🇺🇦 Ukraine

🇺🇿 Uzbekistan

Enquire About Storage →

Storage of Products

GDP-compliant temperature-controlled storage for pharmaceutical products under continuous monitoring conditions.

Receipt & Checking of Goods

Systematic goods-in procedures including identity verification, quantity checking, and damage inspection on arrival.

Order Preparation & Shipment

Professional pick, pack, and dispatch services with full documentation trail for outbound pharmaceutical shipments.

Logistical Support & Documentation

Complete logistics coordination and GDP-compliant documentation including batch traceability and delivery records.

Bulk Storage

High-capacity bulk storage solutions for raw materials, APIs, and finished products in GMP-approved facilities.

GDP compliant pharmaceutical warehouse facility

Temperature controlled pharmaceutical storage

Service 11

Turnkey Projects

Greenfield pharmaceutical facility development — from concept to fully operational GMP-compliant manufacturing unit. Complete project lifecycle support across Europe, India, CIS & Africa.

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Feasibility & Master Planning

Capacity calculation, business plan preparation, and comprehensive site master planning from concept stage.

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Facility Design & Engineering

Detailed plant layout engineering, utility system planning, HVAC, water systems, and cleanroom solutions.

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Construction & Commissioning

Construction supervision, equipment installation, and full commissioning to ensure operational readiness.

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Regulatory Approval & Validation

Integrated GMP compliance aligned with FDA, WHO, EU GMP, MHRA, and PIC/S from day one.

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Plant Modifications & Retrofit

Upgrading, retrofitting, and expanding existing pharmaceutical facilities with minimal operational disruption.

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Automation & System Integration

Automation and control system integration, electrical upgrades, and fire safety infrastructure improvements.

Single-Point Responsibility.
From Concept to Compliance.

One partner managing your entire Greenfield or modification project — eliminating coordination risk and ensuring GMP compliance at every phase.

Service 12

Technology
Transfer

Structured transfer of knowledge, documentation, processes, and manufacturing capabilities of medicinal products from one site or organization to another — ensuring consistent quality at commercial scale.

R&D → Production plant transfer

Site-to-site transfer

Pilot scale → Commercial scale

Contract manufacturing transfer

Discuss Your Transfer →

6 Main Stages

Technology Transfer Process

Knowledge Transfer

Sharing complete product and process understanding — formulation details, manufacturing steps, and critical quality attributes.

Gap Assessment

Identifying differences between sending and receiving sites — equipment, processes, regulatory requirements, and capabilities.

Process Adaptation

Aligning equipment operating parameters and conditions at the receiving site to match the transferred process.

Pilot / Trial Batches

Execution of trial batches at the receiving site to confirm process reproducibility and product quality.

Validation Batches

Formal validation batches with full documentation to confirm consistent reproducibility at commercial scale.

Regulatory Approval & Routine Manufacturing

Submission of regulatory dossier amendments and transition to full routine commercial production.

Our Services &Solutions

GxP Audits &Supply Chain