CEO & MANAGING CONSULTANT
International Speaker, Trainer, Auditor, Mentor Visiting Faculty, GMP, Quality and Regulatory Compliance Consultant & Scientific and Technical Advisor,
GAP analysis/ Due Diligence for Pharmaceutical companies to check the health of GMP Compliance
Customized GMP Training Programs …..
We undertake risk-based audits for ensuring compliance and GMP standards
Preparation of Validation Master Plan….
Design of documentation templates/ formats for ADL, QA, QC, Microbiology, Warehouse, Regulatory Affairs functions, Manufacturing , IT….
Review of exiting GMP system to check the status of compliance and to identify gaps
Regulatory filings of generics ANDA/ANDS/MAA etc. to US, Europe, Canada, Japan, ASEAN Countries, TGA, ANVISA and..
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”
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.