GMP Compliance and Regulatory

QxP Pharma Consultants – Your Trusted Partner in GMP Regulatory Compliance Consulting
Ensure your pharmaceutical operations meet the highest standards of quality and regulatory expectations with QxP Pharma Consultants & GMP Services—India’s trusted partner for end-to-end GMP and regulatory compliance solutions.
From GMP Quality System Implementation to FDA GMP Compliance Consulting, we deliver strategic support tailored to your facility’s needs.

As leading Pharma Consultants in India, we provide comprehensive services for GMP Compliance Services, Pharmaceutical Regulatory Compliance, and audit readiness, helping you achieve excellence in compliance.

Why GMP Compliance and Regulatory Support is Critical?
In today’s tightly regulated pharmaceutical landscape, adherence to Good Manufacturing Practices (GMP) is not optional—it is essential.
Whether manufacturing APIs, finished dosage forms, or biologics, companies must comply with national and international regulations such as 21 CFR Part 11, EU GMP, WHO GMP, and ICH Guidelines.
Regulatory non-compliance can lead to serious consequences, including product recalls, import bans, and even facility shutdowns.
That’s why partnering with experienced consultants like QxP Pharma Consultants in Ahmedabad ensures your facility stays inspection-ready and meets global regulatory standards.

GMP Gap Analysis
Our GMP Gap Analysis service identifies existing shortcomings in your facility, documentation, and processes compared to GMP requirements. QxP Pharma Consultants help evaluate compliance with:
EU GMP guidelines
US FDA regulations
WHO GMP
Schedule M and ICH guidelines
Through detailed audits and risk assessments, we provide actionable recommendations and a prioritized remediation plan.

GMP Quality System Implementation
We design and implement GMP-compliant Quality Management Systems (QMS) to ensure full regulatory alignment. Our QMS services include:
SOP development
Deviation and CAPA management
Change control processes
Internal audit systems
Documentation control and training systems
This service is crucial for companies seeking GMP Certification Support Services in India or internationally.

Regulatory Affairs Consulting Services
With a rapidly evolving pharma regulatory framework, navigating the complexity of compliance requires deep domain expertise.
QxP offers Regulatory Strategy and Compliance solutions that align your operations with current global expectations.
QxP offers Regulatory Strategy and Compliance solutions that align your operations with current global expectations.

Regulatory Documentation Services
We support clients with the development, review, and submission of high-quality documentation for:
DMFs, ANDAs, NDAs
Dossiers for EU and ROW markets
Site Master Files
Product Quality Reviews (PQRs)
Validation protocols and reports
Our team ensures all documents meet the requirements of target regulatory bodies.

Regulatory Audit Support Services
Be audit-ready, always. We help clients prepare for and manage inspections by regulatory authorities such as:
US FDA
EMA
WHO
CDSCO
Our GMP Inspection Readiness programs include mock audits, audit trail reviews, data integrity checks, and pre-audit documentation reviews to ensure smooth and successful inspections.

21 CFR Part 11 Compliance
In today’s digital environment, electronic records and signatures must comply with 21 CFR Part 11. QxP offers:
Gap assessments of existing computerized systems
Risk-based validation aligned with GAMP 5 Standards
Audit trail integrity checks
Electronic signature configuration and documentation
These services are ideal for pharma and biotech companies undergoing GMP Services Providing in India that require electronic compliance.

Compliance with GAMP 5 Standards
Our GAMP 5-based Computer System Validation (CSV) services help you meet regulatory expectations for data integrity, traceability, and system security. We offer:
GAMP-compliant validation planning
Risk-based testing protocols
Lifecycle documentation
Periodic review and revalidation strategy
Our experts ensure your systems meet the strictest standards in GMP Regulatory Compliance Consulting India.

Turnkey Regulatory and GMP Project Support
We offer end-to-end compliance support as part of our Turnkey Project services. From design and commissioning to validation and regulatory approval, QxP Pharma Consultants deliver full-cycle GMP support, including:
CQV documentation
Regulatory dossier compilation
Vendor qualification
GMP Documentation Services
Training and QMS handover
Whether launching a new facility or upgrading existing infrastructure, our team provides complete regulatory and GMP oversight.

Why Choose QxP Pharma Consultants & GMP Services?
With over a decade of experience and a team of multidisciplinary experts, QxP Pharma Consultants is known for its deep understanding of global compliance standards.
Based in Gujarat, we offer GMP Services Providing in Ahmedabad and across India to clients ranging from start-ups to multinational pharmaceutical corporations.

Key Advantages:
Customized Solutions: Tailored compliance plans for your operations and regulatory goals.
Audit Readiness: Proven support for successful USFDA, WHO, EU GMP inspections.
Regulatory Foresight: Stay ahead of evolving global compliance trends.
Cross-functional Expertise: Covering QA, QC, CSV, regulatory, engineering, and manufacturing.
Nationwide Reach: Recognized as one of the top Pharma Consultants in India for GMP Compliance Services.

Contact Us for Pharma Regulatory Compliance Support
Ready to achieve audit readiness and GMP compliance excellence?
Whether you’re establishing a new facility, preparing for regulatory inspection, or upgrading your documentation and QMS systems, QxP Pharma Consultants & GMP Services is your trusted partner for GMP Regulatory Compliance Consulting India.
Let us help you simplify compliance while building quality into your systems from the ground up.

QxP Pharma Consultants – Your Trusted Partner in GMP Regulatory Compliance Consulting