Leading Regulatory & GMP Services Provider in India

In the highly regulated pharmaceutical industry, compliance with global regulatory standards is critical for success. QxP Pharma Consultant is a leading regulatory services and GMP compliance firm, offering solutions to pharma, biotech, and medical device companies.
Our experts ensure your operations meet international regulations, enabling you to focus on innovation and growth.

QxP Pharma Consultants offers regulatory services to ensure your products comply with all necessary standards. Our expertise includes:
Regulatory Strategy & Compliance: We offer guidance on regulatory pathways, product classification, and compliance strategies for markets like FDA, EMA.
Dossier Preparation & Submission: Compilation, submission, and lifecycle management of regulatory submissions, including CTD, eCTD, and ACTD dossiers.
Regulatory Audits & Inspections: Preparation, support, and gap analysis for regulatory audits by international agencies.
CMC (Chemistry, Manufacturing, and Controls) Consulting: Assistance with manufacturing processes, stability studies, and quality control documentation.
Post-Approval Regulatory Support: Variation filing, license renewals, and pharmacovigilance compliance.

GMP Compliance & Quality Assurance:
Ensuring Good Manufacturing Practice (GMP) compliance is crucial for maintaining product quality and safety. Our GMP consulting services include:
GMP Audits & Inspections: Conducting internal and supplier audits to ensure compliance with WHO GMP, EU GMP, US FDA GMP, and other standards.
Quality Management System (QMS) Implementation: Developing and implementing QMS for streamlined compliance and operational efficiency.
Data Integrity & Validation: Ensuring compliance with ALCOA+ principles for data integrity in pharmaceutical operations.
Training & Workshops: Providing hands-on training for employees on GMP, regulatory compliance, and quality assurance best practices.

Regulatory Services