Pharma Validation & Consulting Services
Your trusted partner for comprehensive pharmaceutical validation and compliance solutions.
With years of technical expertise and a commitment to excellence, we deliver services that ensure regulatory compliance, operational efficiency, and product quality.
About Us
Since 2019, Cleanstep Pharma and Engineering Solutions has been providing validation, qualification, engineering, and GMP consulting services to the pharmaceutical, biotechnology, medical device, healthcare, and life sciences industries.
Our multidisciplinary team brings extensive practical experience across Computer System Validation, Commissioning, Qualification & Validation, HVAC, Utility and Thermal validation, laboratory systems, GMP Support Services, pharma training and consultancy, and third-party auditing.
As an ISO 9001:2015 Certified organization, we help regulated companies achieve compliance, quality, and operational excellence through risk-based validation solutions for facilities, utilities, equipment, computerized systems, laboratory instruments, and manufacturing processes.
With a strong focus on quality, technical excellence, and regulatory compliance, we deliver practical solutions that support our clients throughout the lifecycle of their GxP systems and operations.
Our Vision
“To be a globally trusted validation and compliance partner, enabling regulated industries to achieve excellence in quality, safety and regulatory compliance through innovative, reliable and customer-focused solutions.”
Our Journey
Cleanstep Pharma & Engineering Solutions was established in 2019 and has earned the trust of leading pharmaceutical and biotechnology companies through its expertise in validation and engineering services.
As part of our long-term growth strategy, we have established Cleanstep Global Technologies Pvt. Ltd., which will continue and expand these operations with broader capabilities in technology, engineering, digital transformation, and regulatory consulting.
To ensure seamless continuity, Cleanstep Pharma & Engineering Solutions will continue to support its existing customers under the same name, while all new business, corporate communications, and future growth initiatives will be undertaken through Cleanstep Global Technologies Pvt. Ltd.
Our management team, technical experts, commitment to quality, and service standards remain unchanged.
Our global strategies partner
Partner with Pioneer Quality Experts in Saudi Arabia.
Pioneer Quality Expert
Powered by Trusted Partnerships
Together with our partners, we deliver innovative engineering, validation, and compliance solutions that help pharmaceutical companies achieve excellence worldwide.
Collaborating for Compliance and Innovation
Powered by Trusted Partnerships
Together with our partners, we deliver innovative engineering, validation, and compliance solutions that help pharmaceutical companies achieve excellence worldwide.
Collaborating for Compliance and Innovation
Rajendara Nagori
Founder & Director Infill Life Sciences
A skilled researcher with an educational background in Pharmacy and worked in Pharmaceutical Formulation development field at various levels of management hierarchy.
More than 34 years of total experience in the field of Research and Development (R&D) for pharmaceutical products. He has an extensive experience in the development of formulations for Generic Pharmaceutical product development for US market, Generic Pharmaceutical Product development for Europe market, Formulation development of New Chemical Entities for various phases of clinical trials, Pharmaceutical Product development for Rest of the world market, pharmaceutical product development for Indian market, Injectable formulations for veterinary use
Manojkumar Agrawal
SME – Quality & Regulatory
Manoj has more than 29 years of experience in various areas of pharmaceutical industry which includes Regulatory Affairs, QMS, Compliance, Vendor Audits, Manufacturing, Validations and Sterile API manufacturing. He has extensive experience / expertise in active pharmaceutical ingredients (API) and finished dosage form. His operational and analytical understanding are an additional benefit while designing a robust regulatory strategy for various complex projects. Well experienced in facing facility inspections conducted by regulatory authorities (US FDA, MHRA, EDQM and other Health Authorities). Manoj expertise includes submissions and approval of dossiers through various regulatory authorities including USA and EU. Attended multiple training programs and conferences.
Nayeem Syed
Nayeem has more than 21 years of experience in various areas of pharmaceutical industry which includes Regulatory affairs, Quality, Regulatory Compliance and Formulation Development. He is well experienced in submissions and getting approval of dossiers through regulatory authorities including USA and EU. He has submitted multiple scientific advice/meeting packages to health authorities (USA and EU) for IND and generic products and participated into face-to-face meetings. He was responsible for designing regulatory strategies for oral solid (tablet, capsules), oral liquid, complex generics (LMWH, drug + device combination products, controlled release injectable). He has done regulatory due diligence / facility audits of both Indian and international companies (USA, UK, France, Canada, Belgium, China). Well experienced in facing facility inspections conducted by regulatory authorities (US FDA, MHRA, EDQM and other authorities). Has publication in national and international research journals. Attended (e.g. Culture of Quality) and was speaker in multiple training programs and conferences (e.g. GPhA USA).
Amit N Patel
Our Strategic Partner – FDA Geek
Founders
FDA Geek is a Certified Minority Business Enterprise (MBE) providing specialized quality and regulatory compliance consulting services to FDA-regulated industries, including pharmaceutical, biotechnology, medical device, and food companies.
Through our strategic partnership with FDA Geek, Cleanstep Pharma & Engineering Solutions strengthens its capabilities in delivering comprehensive quality, regulatory, validation, and compliance solutions to our clients.
FDA Geek brings extensive expertise in FDA regulatory requirements and quality systems, with a strong focus on delivering cost-effective, practical, and high-quality consulting solutions. Their commitment to regulatory excellence, operational efficiency, and customer satisfaction complements Cleanstep’s technical and validation expertise.
Together, Cleanstep Pharma & Engineering Solutions and FDA Geek aim to provide integrated solutions that support our clients throughout their compliance, validation, quality, and regulatory journey, while building long-term and trusted client relationships.
Our partnership combines technical expertise, regulatory knowledge, and a commitment to quality to deliver reliable and value-driven solutions to FDA-regulated industries.
Quality Policy
We at Cleanstep Pharma and Engineering Solutions believe that the establishment of an
effective Quality management system will help our firm achieve its vision of becoming a highly
respected service firm in the Pharma industry.
Customer-Centric Approach
Addressing the needs and expectations of our customers in a timely manner and satisfying customers with our services as our top priority.
Continuous Improvement
Continually improving our processes and manpower
through operational and innovative training.
Technical Excellence
Creating high-quality, inspection-ready documents with expert technical writing skills and a renowned SME network from the industry.
Specialized Support
Developing and maintaining robust assurance and validation practices with focused technical, quality, and compliance support.
Why Choose Cleanstep?
Comprehensive Validation & Compliance Solutions
Industry Expertise
Our team members bring decades of combined pharmaceutical experience across sterile, non-sterile, and API manufacturing environments.
Regulatory Knowledge
Deep understanding of global regulatory requirements, including FDA, EMA, WHO, MHRA, SFDA, and CDSCO
and other regulatory bodies.
Comprehensive Solutions
End-to-end validation and consulting services to address all your quality and compliance needs.
Proven Track Record
Trusted by leading pharmaceutical
companies as demonstrated by our extensive client portfolio.
