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Sai Pharma Solutions
“Working with Sai Pharma Solutions has been a game-changer for our regulatory compliance. Their expertise and attention to detail are commendable. Highly recommended!”
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Sai Pharma Solutions
“Sai Pharma Solutions helped us navigate complex regulatory processes seamlessly. Their commitment to quality and timelines is unmatched.”
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Sai Pharma Solutions
“We’ve been associated with Sai Pharma Solutions for over five years. Their personalized approach and in-depth knowledge have been instrumental in our success.”
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Sai Pharma Solutions
“Sai Pharma Solutions transformed our quality systems. Their team is responsive, efficient, and always goes the extra mile.”
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International Speaker, Trainer, Auditor, Mentor Visiting Faculty, GMP, Quality and Regulatory Compliance Consultant & Scientific and Technical Advisor,

Our Services

Audit, Gap Analysis & Compliance

GAP analysis/ Due Diligence for Pharmaceutical companies to check the health of GMP Compliance

Training & Quality Culture Build up

Customized GMP Training Programs …..

Vendor/Supplier Qualification

We undertake risk-based audits for ensuring compliance and GMP standards

Validation and Qualification

Preparation of Validation Master Plan….

Documentation and SOP management Support

Design of documentation templates/ formats for ADL, QA, QC, Microbiology, Warehouse, Regulatory Affairs functions, Manufacturing , IT….

Preparing for Global GMP and Regulatory Compliance

Review of exiting GMP system to check the status of compliance and to identify gaps

Regulatory Affairs and Compliance Services

Regulatory filings of generics ANDA/ANDS/MAA etc. to US, Europe, Canada, Japan, ASEAN Countries, TGA, ANVISA and..

GMP & Regulatory Remediation

Review adequacy of SOPs, qualification and validation to meet compliance according to international quality…


“Sai Pharma Solutions Inc. has been instrumental in providing services on consultation and turnkey project basis in Regulatory Affairs, Quality Management and GMP compliance since 2008. We offer consultation and undertake turnkey projects in development and implementation of Quality Systems which incorporates Regulatory Affairs, Quality and cGMP documentation, DMF and Dossier Management, SOP Management, Technical and Scientific Advice management, Validation and Qualification Management, Gap Analysis, Review, Assessment, Audits and Training. Our clientele includes the upcoming and existing pharmaceutical industries. We are known for the best” QQS” worldwide. The quality of our work speaks volumes about our efforts and endeavors”


“Sai Pharma Solutions transformed our quality systems. Their turnkey projects helped us achieve GMP compliance swiftly. Their team’s attention to detail, from DMF management to validation protocols, is commendable. We highly recommend their services.”
“Working with Sai Pharma Solutions has been a game-changer for our company. Their expertise in regulatory affairs and quality management is unparalleled. They guided us through complex compliance requirements, streamlined our processes, and ensured our documentation was top-notch. Their commitment to excellence truly sets them apart.”
 “We’ve collaborated with Sai Pharma Solutions for years. Their audits and gap analyses have been instrumental in maintaining our high standards. Their training programs are engaging and effective. Sai Pharma Solutions is our trusted partner.”

We look forward to working with you and helping your organization achieve its quality and compliance goals. Thank you for considering us as your partner in excellence.