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

1. CORPORATE OVERVIEW
www.saipharmaconsultants.com
info@saipharmaconsultants.com

2. ABOUT US
2
▰ 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

4. OUR COMPETENCIES
AUDITS & COMPLIANCE MANAGEMENT
PROJECT MANAGEMENT
PHARMACEUTICAL DEVELOPMENT
REGULATORY AFFAIRS
QUALIFICATION & VALIDATION
OPERATIONAL EXCELLENCE
TRAINING
4

5. OUR SERVICES TO INDUSTRY SECTORS
5
 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
6

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
7

8. CONCEPT ENGINEERING SERVICES
 Plot & Contour Planning
 Plant Layout
 Man & Material Movement Details
 Preliminary Architectural Drawings
 HVAC Concepts
 Preliminary Utility Specifications
 Power Requirement Estimation
 Preliminary Project Cost Estimation & Scheduling
 Environmental & Safety Engineering
 Future Expansion Possibilities
8

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
9

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
10

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)
11

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
12

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
13

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)
14

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
15

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.
16

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

18. SOME OF OUR CLIENTS
18

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
19