Exclusively led by the very best in the business
Qualified Persons (QPs) & Responsible Persons (RPs)
REN Pharma Sciences Limited is a specialist pharmaceutical consultancy providing end-to-end expertise in Quality Assurance and complementary services across both clinical and commercial domains
ABOUT
Our Experts Are the Finest
Naresh Renikindi
Founder & Principal Consultant
(QP/RP/RPi)
A Pharmacist with a postgraduate degree in Pharmaceutical Sciences and a Qualified Person (QP) under the permanent provisions of 2001/83/EC, bringing over 18 years of comprehensive experience in Quality Assurance, Production, Quality Control, Validation, and Regulatory Affairs. Expertise spans in Pharmaceuticals, Medical Devices, Borderline Products, and Combination Products. A seasoned Lead Auditor with deep knowledge of Quality Management Systems (QMS) and Quality Risk Management (QRM), having conducted over 250 audits worldwide covering Pharma-GMP, GDP, GVP, ISO 9001, and ISO 13485 standards for Medical Devices.
Puneet Kumar
Consultant
(QP/RP/RPi)
A highly experienced pharmacist, a postgraduate degree in Pharmaceutical Sciences and a Qualified Person (QP) and Responsible Person (RP). Additionally deemed to eligible by the MHRA as a Compliance Monitor (CM), bringing over 42 years of extensive international expertise in Quality Assurance, Production, Quality Control, and Regulatory Affairs across the spectrum of dosage forms. Furthermore, a Lead Auditor with deep proficiency in Quality Management Systems (QMS) and Quality Risk Management (QRM), having successfully conducted over 150 audits worldwide across Pharma-GMP, GDP and ISO 9001.
>75
Years of collective experience
>25
Clients
across globe
500+
Audits
7
MIA / WDA
OUR SERVICES
Taking Your Business to the Next Level
Qualified Person (QP) Services
From GMP Phase I to Post-marketing, we provide full QP oversight including Batch review and release for small & large molecules including advanced mRNA vaccines, CAR-T products for UK &EU.
Responsible Person (RP/RPi) Services
Comprehensive Good Distribution Practice (GDP) compliance with experienced RP/RPi support tailored to your distribution model.
GMDP Auditing
Risk-based auditing strategies for GMP and GDP—from early-phase to commercialization—including due diligence, pre-inspections, and mock audits.
New MIA & WDA Setup
Custom Quality Management Systems (QMS) designed for compliance with MHRA and EMA requirements, guided by expert QP/RP consultants from setup to operations.
GMDP Training
Tailored training programs for GMP compliance, auditing techniques, and validation practices to empower your operational teams.
Remediation Programs
Support for regulatory findings—from audit response to CAPA execution—ensuring full alignment with MHRA, EMA, and USFDA expectations.
Project & Interim Management
Leadership support for critical GxP projects and interim senior roles, focused on delivering efficiency, compliance, and operational excellence.
CONTACT
Let’s Work Together
