D Ramesh Babu

Project management (C&Q) for new facilities X

GXP Auditing, Gap Analysis and Remediation X
GXP Documentation support X
Training on GXP guidelines
Quality Risk Assessment (API & Formulation) X
Computer System Validation (Level 0 to Level 4)
Making the facility in compliance to WHO - GMP, MHRA, EU, USFDA, and PIC/S X
FDA 483 Remediation X
Data Integrity Audits X
SOP Development X
FRS Development X
FAT Development X
Traceability Matrix X
PQ - PV and CV Development X
Validation Document Formatting X
Commissioing and Qualification X
Process Validation (PV) & Cleaning Validation (CV) X
Quality and Regulatory Complaince (Whole) X
Process Development X
Serialization Validation X
 Name Skill

D Ramesh Babu
GDP Audit
CRO (GCP) Audit
Bioassays
Biostatistics
Bio-analytical
Bioassays Training (USP)
Bacterial Endotoxin testing training
(USP)
Antibiotic Potency Testing Training
(USP)
Bio-lab Setup
Pharma-QC Lab Setup
Bioavailability and
X

Bioequivalence Studies
GLP Audit
R&D / Clinical Trails / Drug Release to the Market

Lab Instrument Calibration &

Qualification
Regulatory Compliance Submissions
R&D Analytical Training
 Pharma Technology Transfer &
Scale-up
Biotechnology Transfer &

X
Scale-up
QMS Establishment

X X
QMS/QA GMP Audit
API - Intermediate - Excipient
Supplier Audit

X
GMP Audit (OSD/OLD)
GMP Audit (Vaccine)
GMP Audit (Sterile)

X X
GMP Audit (Biologics)
EHS Audit
GMP Audit (API)
GMP Audit (Supplier )
CMO Audit
Facility Validation
(API - Non Sterile)
Facility Validation
(API - Sterile)
Facility Validation
(Formulation - Non Sterile)
Facility Validation
X

(Formulation - Sterile)
Facility Validation
X

(Biologics)
Clean Room Validation
Utility Validation
X X X

HVAC Validation
Drug Manufacturing
 Process Validation API

X
(Pharma - Non Sterile)
Process Validation API
(Pharma - Sterile)
Drug Manufacturing

Process Validation API

(Biologics)
Process Validation
Formulation (Non-Sterile)
Process Validation

X
Formulation (Sterile)
Process Validation

X
Biologics
Process Validation
X Vaccines
Cleaning Validation
Analytical Method Validation
Data Integrity Audit
X X X X

Equipment Validation
Commissioning and
X

Qualification
LIMS Validation
BMS Validation
CSV Part 11
(ERP, MES, SCADA)
CSV Training
X

GMP Training
GLP Training
GCP Training
GDP Training
X X

QMS Training
 Post Review and providing solutions on

X
FDA observation
Project - API
Mechanical
Project Consultant API
Non-Sterile
Project Consultant API
Sterile
Project Consultant
Formulation - Non Sterile
Project Consultant
Formulation - Sterile
Project Consultant
Biologics
Project Execution

Project Consultant (All)

Clean Room Supply, Commissioning
and Validation
Waste Water Treatment - ETP/SWT
Track and Trace
Regulated Facility Design Support

US FDA
UK MHRA/EU EDQM
X X X

SA MCC
Aus. TGA
PIC/S
Brazil ANVISA
WHO GMP
X X

Indian Schedule M
Regulatory Compliance
INFARMED
KFDA
gulatory Compliance

SFDA
ISO 13845 (Medical Devices)