Founded in 2011, QualyInc was established with a singular focus: to help domestic pharmaceutical manufacturers in Hyderabad align their operations with international regulatory standards. Today, we are proud to be one of India's leading GxP compliance advisory firms, serving bulk drug, formulation, and biological manufacturers nationwide.
We believe that regulatory compliance is not just about passing an inspection—it is about designing stable, repeatable processes that assure product quality. Our team consists of former regulatory experts, senior microbiologists, and validation engineers with deep familiarity in US FDA, WHO GMP, MHRA, and EMA rules.
We support facilities through every stage of their design, validation, commercial production, and remediation lifecycles.
Assessing blueprints, airflow designs (HVAC), clean utilities, and formulating robust protocols (DQ, IQ, OQ) before production runs begin.
Drafting sound QA/QC SOPs, configuring secure document controls, validating analytical instruments, and establishing validation Master Plans (VMP).
Continuous data integrity reviews, periodic quality risk assessments, employee GMP hygiene training, and strict change control oversight.
Executing zero-notice simulated inspections, preparing site subject matter experts (SMEs), and supporting your team in front of foreign auditors.
Led by industry pioneers who bring decades of combined experience in global pharmaceutical regulatory audits.
Managing Director & Chief GxP Advisor
With over 25 years of pharmaceutical QA consulting history, Dr. Rao has guided more than 100 facilities in Hyderabad through major regulatory clearances.
Director, FDA Response & Remediation
A veteran validations engineer, Ramakrishna leads our emergency warning letter response task force, working actively to resolve regulatory blocks.
Head of Laboratory Audits & Sterile QA
Dr. Priya oversees sterile process controls, HVAC qualification systems, and coordinates site personnel training protocols in micro-aseptic methods.
