T.Rama Rao is a Sr.Consultant & Promoter of M/s.Saipharma Consultancy with Team Members having rich experience in handlig Project Management, Audits & Compliance Management, Regulatory Affairs, Pharmaceutical Product Development, GxP Training/ Operational Excellence
We work with Micro ,Small ,Medium and Large Enterprises in Pharma Formulations/Intermediates ,APIs,& Chemicals / Medical Devices/ BioTech / AYUSH/ Primary Pkg Mtrs/ Clinical Research Organisation .
Please visit our web site www.saipharmaconsultants.com for further details
2. ABOUT US
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▰ Commitment to Our Clients
▰ Commitment to Quality & Delivery
▰ Experience in Industry
▰ Commitment to Economic &
Sustainable Design
▰ We endeavour to deliver on our
commitments to our clients, focusing
on transparency, results and high
standards. We provide tailor-made
solutions to meet clients, business and
project goals. We aim to build long-
term relationships with our clients
▰ T.Rama Rao is the Sr. Consultant
& Promoter of Sai Pharma
Consultancy having the Core
Team members with rich
experienced to handle Project
Management, Pharmaceutical
Product Development, Audits &
Compliance Management,
Regulatory Affairs & GxP Training
3. 3
T. Rama Rao
Sr. Consultant & Promoter
M.Pharm (30 yrs Exp)
Mr. A.G. Ganu
Director Projects
BE-BITS (35 yrs Exp)
Dr. S. Raviprakash Reddy
Director ,Regulatory Affairs
M.Sc, MBA, Ph.D. (25 yrs Exp)
V. R.Majumdar
Director Operations
(API & Chemicals)
B.Sc Tech (33yrs Exp)
Dr. VSS. Murthii Director
Audits & Compliance Mgmt
M.Sc, Ph.D, (25yrs Exp)
Dr. Kumar V.S. Nemmani
Director -Pharmaceutical Development
M. Pharm., Ph.D (15yrs Exp)
Ms. T. Manjula
Director Finance
(30yrs Exp)
TEAM MEMBERS
5. OUR SERVICES TO INDUSTRY SECTORS
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Nuetraceuticals /Dietary
Supplements
Food Products
Excipients
Primary Packing Materials
Public Testing Laboratories,
Educational Institutions
Pharma Formulations
( Sterile and Non sterile)
Intermediates & API’s
Medical Devices
Biotech & Biologicals
AYUSH
Clinical Research Organisations
(CRO)
6. AUDITS & COMPLIANCE MANAGEMENT
Good Manufacturing Practices (GMP) Audits & Compliance support in accordance
with :
USFDA- CFR 210-211,CFR -110, CFR-111
PIC/S , EU (Eudralex Vol 4) ,MHRA, TGA , ANVISA ,WHO GMP,etc
Good Laboratory Practices (GLP) including support for NABL Certification
Good Clinical Practice (GCP ) Audits
Facility Feasibility Audits and Gap Analysis
Good Distribution Practices
Good Documentation Practices
Data Integrity Audits
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7. PROJECT MANAGEMENT SERVICES
Provide the Services for New Projects / Modification of Existing Plants
Complete Engineering Consultancy for industries from sectors like Formulations,
Bulk Drugs, Biological Products (Vaccines) & IV. It covers HVAC, Electrical, Water
Systems, Steam and Piping & Insulation.
Audit of Utility Services, check performance v/s URS, IQ, OQ, PQ documents and
report on variance.
Energy Audit.
Training of engineering personnel for PLM of Formulations & vaccines & Utilities on
Systems, Operations & maintenance.
Preparation of Validation documents
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9. PHARMACEUTICAL DEVELOPMENT
Our team is capable of conducting breakthrough research and overcoming formulation
difficulties with Cost effective product development. We do the Development of the
product in the existing labs up to advance stage
Formulation Development
Reformulation
Preclinical and Clinical Development
Technology Transfer
Qualification & Validation
Setting Up of New R&D facility, New pilot plant
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10. DOSAGE FORMS HANDLED FOR DEVELOPMENT
Oral Solid Dosage forms ( Tablets, Capsules, Pallets, EVT, Dry Syrups ,Sachets)
Small & Large Volume Parenterals
Vaccines ( General & Genetically Modified )
Eye drops / Nasal sprays
Liquid oral dosage Forms (Syrups, Suspensions, Emulsions, Lotions, Solutions)
Semi Solid Dosages Forms ( Ointments, Creams, Gels)
Bio technology based Products
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11. DOCUMENTATION & VALIDATION SUPPORT
We Support in the Drafting and Documentation of
Specifications
Standard Operating Procedures(SOPs)
Quality Management Systems
Validation & Qualification
Master Formula records ( MFR)
Batch Manufacturing Records(BMR)
Batch Packing Records ( BPR)
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12. REGULATORY AFFAIRS
We support in :
Dossier Preparation & Review
Drug Firm Establishment Registration with US-FDA [United States’ Food and Drug
Administration] (FEI [Facility Establishment Identifier])
Preparation of DMF [Drug Master Files]/ ASMF [Active Substance Master File] / CEP
[Certificate of Suitability] or (CoS) / KDMF/ Technical Packages
Regulatory Filing Support & Review
Response Strategy & Response Drafting
Response Documentation Review & Issue Resolution Plan
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13. TRAINING SERVICES
We conduct Customised Trainings to employees at all levels who are engaged in the
manufacture / storage / distribution on the below mentioned concepts :
Good Manufacturing Practices ( GMP)
Good Laboratory Practices ( GLP)
Good Documentation Practices ( GDP)
Good Warehousing & Distribution Practices
Qualification & Validation
Auditing & Compliance Management
Pilot Plants & Technology transfer
Regulatory Guidelines
ICH / PIC/S / WHO GMP Guidelines
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14. OPERATIONAL EXCELLENCE
We are specialised in providing the services for
Optimisation of Process Cycle times.
Waste Reduction.
Cost optimisation of Products
Optimisation of Overhead Costs.
Optimisation of Cleaning Times.
Optimisation of Man power.
Productivity Improvements.
Supply Chain Management (SCM)
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15. EDUCATIONAL INSTITUTIONS
We are conducting interactive sessions with the Graduate /Post Graduate Pharmacy
students of reputed colleges in India on the below subjects
Quality Control & Quality assurance
Regulatory Affairs
GMP Guidelines
Industrial pharmacy
Pilot Plants ,Technology transfer
Scale Ups & Validations
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16. PARTNERS & ASSOCIATES
PharmEng Technology, Singapore:
Global compliance Consulting firm serving both Bio Tech & Pharma Industry
Compliance Online :
Is an Industry focused training Centre based in California(USA),
Andhra Pradesh MedTech Zone Ltd, (AMTZ) Visakhapatnam :
Enterprise under the Government of Andhra Pradesh, a 270 Acre zone, dedicated for
Medical Device Manufacturing
Educational Institutions:
1) Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, India.
2) G.Pulla Reddy College of Pharmacy, Hyderabad, Telengana ,India.
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17. TESTIMONIALS
Please refer our website testimonials page about few words from our customers
Om Pharmaceuticals Ltd, Bangalore
Neuheight Technologies Pvt Ltd, Hyderabad
Award from Director General of Drug Control Admn. of Andhra Pradesh
Award of Certificate from Kakatiya University , Warangal,Telangana State
Award of certificate from Central Drug Standards Control Organisation(CDSCO),New
Delhi
Project Excellency Award by P & G Hygiene and Health Care Ltd
Appreciation Certificates from Procter & Gamble Hygiene & Health care Ltd
a) Mr. Prajay Desai b) Mr. Ashish Dubey c) Ms. Subha Subramanian
d) Mr. Homi Kotiwala e) Mr. Sanjay Mishra 17
19. REACH US AT
T. Rama Rao
Regd Office:
Flat no 302, Air Lines Apartments
Jayanagar Colony, New Bowenapally
Hyderabad -500011, Telengana State, India
Mob No: +91 9985538854
Ph.No: +91 4027758360
E Mail : info@saipharmaconsultants.com
Web Site: http://saipharmaconsultants.com
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