Pharmaceutical Regulatory Affairs, Quality Managment and GMP Compliance Services

1. Dear Sir/Madam;
Greetings from Sai Pharma Solutions Inc.!
We take pleasure to introduce ourselves as M/s. Sai Pharma Solutions Inc playing a pivotal role
in the world of Pharmaceuticals. We are one of the leading Regulatory and Quality Management
Service Providers and Consultants of India since 2008. Our core activity is preparation of
DMF/Dossiers/CTD/COS/SOPs/BPCRs and all GMP documents. We provide Comprehensive
Solution for Preparation, Filing and Registration & Updates of Drug Master Files (DMF) for API
& Registration Dossiers for Formulations at a single contact point.
QUALITY MANAGEMENT AND GMP COMPLIANCE SERVICES:
NEW MANUFACTURING FACILITY :
SAI PHARMA SOLUTIONS INC. provides support on setting up of a new pharmaceutical or
medical device manufacturing facility. Our support covers Design, Construction, Adaptation of
building, HVAC System, Documentation, Training, Validation and Qualification; Approvals by
the National and International regulatory agencies.
EXISTING PREMISES: EXTENSION, MODIFICATION:
Organizations facing a problem in complying with revised Schedule M, WHO-GMP, USFDA,
PMDA, Japan, Health Canada, ASEAN-GMP, EU-GMP or looking for expansion may seek our
support. We provide them with a revised building layout and HVAC system, Water system and
Building and Facility Construction Requirements as per guidelines. Cost effective solutions are
provided in respect of Building & Documentation. Internal Audit, Qualification and Validation
activities are also undertaken simultaneously.
TURN KEY PROJECTS :
SAI PHARMA SOLUTIONS INC. also offers consultancy for projects on turnkey basis. The
technical support covers aspects of Land Selection, Estimates, Building Designing; Selection for
Contractors for Civil work, Air Handling Systems, Electrical and Plumbing Work, Supervision
of Construction, Equipment Selection; Validation and Qualification; Selection of Personnel and
their training; Documentation; Initiation and Operation of plant; Certification for GMP/ISO
9001-2008,ISO-14001SO-18001,ISO-22001/NABL and other international approvals.

2. AUDIT OUTSOURCING :
Due to limited man power, at times companies are not able to effectively conduct audit of their
vendors/suppliers. SAI PHARMA SOLUTIONS INC. offers audit support to companies who
would like to outsource this task.
DOCUMENTATION:
Documentation is an essential part of Quality Assurance and hence shall cover all aspects of
GMP. Good documentation helps in operation of plant smoothly. SAI PHARMA SOLUTIONS
INC. provides support in developing complete documentation such as Quality Policy, Quality
Manual & Objectives, Site Master File, Procedures, Specifications, Drugs Master File, SOPs,
STPs, Guidelines, Environment Monitoring, Drawings, Flow Charts, BMRs, Formats & Data
Sheets. Documentation also includes Document Distribution & Control, Review System, Change
Control System, Recall, Complaint Handling, Non-Compliance & Non-Conformities. The
employees are guided to prepare documents on their own.
CLIENT-SITE TRAINING :
SAI PHARMA SOLUTIONS INC. also conducts training courses, tailored to meet precise needs
of the client. For this purpose, we use basic principles of dynamic instruction. Client-site training
programme is a cost effective way of training higher number of personnel. An on-site
professional faculty with the required expertise is provided. The participants are not only made
familiar with the selected subjects but also get an opportunity to discuss their technical issues.
TECHNICAL AND SCIENTIFIC ADVISORY SERVICES:
We are also technical and scientific advisors for many companies to support in all issues
pertaining to Quality Management and GMP compliance due to fast changing of guidelines and
requirements.
REGULATORY AFFAIRS COMPLIANCE SERVICES:
ADVISORY SERVICES:
The regulatory affairs team at Sai Pharma Solutions Inc. assists you in navigating through the
regulatory submissions & management process, developing your registration strategy and
helping you in submissions management. Our regulatory affairs team works alongside our

3. clinical and safety experts to author and compile dossiers, in part or in whole, and also to publish
and maintain the dossiers. Our advisory services include but not limited to:
• Global registration strategy
• Interactions with regulatory agencies in emerging markets
• Identification of deficiencies in submissions
• Training and audit preparedness
SUBMISSION MANAGEMENT:
We can advise and help you formulate regulatory and submission strategies across various
markets. Our submission management includes but not limited to:
• Regulatory briefing packages and submissions
• Annual reports (labeling, stability, distribution and CMC changes)
• Dossiers (in CTD, eCTD and ACTD format or country-specific format)
• Supplements, amendments and variations
• Responses to deficiency queries
• Maintenance of labels and reference safety information
REPORT AUTHORING:
We help you maintain compliance after your product secures approval, through its entire
lifecycle, by authoring amendments, variations, annual reports and post approval regulatory audit
responses. Our regulatory affairs team authors specific CMC reports across all the modules of
the dossier which includes but not limited to:
• Quality Overall Summary (QOS)
• Clinical and non-clinical overviews
• Product Quality reports
• Analytical method validation and process development reports
• Stability reports
• Labeling - pack shots and pack inserts
• Site Master File [SMF]
Contact us and identify how we can help you in approval and compliance.
Should you have further queries & any assistance needed from our side, please feel free to
contact us anytime.

4. Thanking you and best regards
J.RAMNIWAS
Founder & CEO
SAI PHARMA SOLUTIONS INC.
(Gateway to Regulatory Affairs, Quality & cGMP Compliance)
102,Shraddha Saburi,
Narayan Gardens, VUDA Road, Gotri -390021
Vadodara (Gujarat) India
Email: jramniwas@saipharmasolutions.com
Phone No: +919558809128
Website: www.saipharmasolutions.com
Our Motto" Start to finish, everything in between".