1. Introduction to
RSServe

2. Introduction
• RSServe is a specialized clinical quality
consultancy firm providing GxP (GCP, GMP,
GPvP, CSV) services to medicine and
healthcare industry
• Founded in Aug2013 by Mr Hitesh Shah
• New member added (Mr Bipin Patel in Nov2015)
• Based out of Mumbai – catering quality services
to clients in the US, EU, India and Asia Pacific
• Customised services depending on clients’
needs.
2RSServe Confidential

3. About Us – Hitesh Shah
• Director – Operations
• More than 15 years of rich experience covering
– Bioavailability/Bioequivalence (BA/BE) studies,
– Pre-clinical studies,
– Clinical Trials,
– Formulation and Regulatory Affairs
• Masters degree in Pharmacology and Post graduate
diploma in Pharmacoeconomics
• Successfully faced regulatory inspections from DCGI –
India, UK MHRA, US FDA, ANVISA – Brazil, WHO, MoH
Turkey, MCC – South Africa and Israel – MoH.
3RSServe Confidential

4. Services – BA/BE Studies
High level Project Management and Monitoring of BA/BE Studies
• Project contract, budgeting and negotiation
• Site Selection/Qualification Visits
– Site Initiation Visits
– On-Site Monitoring Visits
– Site Closure Visits
– Remote Monitoring
• Technical discussion with client and CROs
• Timely and extensive update to clients about the study progress
• Bio-analytical Monitoring (In-process and retrospective)
• Scientific document writing/review (protocol, ICFs, CRFs, CSRs)
• Regulatory Affairs (DCGI submission, BE NOC and T- License)
• Monitored more than 100 BE studies for US FDA and EU
submissions. Audited more 10 BA/BE CRO’s in India.
4RSServe Confidential

5. Services – GCP Auditing
GCP auditing and consultancy services including
• Study/Trial Master Files audits
• Study documents (Protocol, ICFs, CSRs) audits
• Clinical Investigative Sites audits
• Clinical Databases audits
• Statistical Programming (TLFs) audits
• Pharmacovigilance audits
• 3rd
party vendors audits (including Clinical laboratories, CROs, Drug
depots, Phase I Units, BA/BE units), Translators and ECs)
• For cause situations (including root cause analysis and Corrective
and Preventive actions (CAPA) program) Process audits
• Management of audit programs.
5RSServe Confidential

6. Services – CSV
Total validation services:
• Validation Strategy and Implementation
• Computer Systems Validation
• Network and Infrastructure Qualification
• Document Management Systems
• Clinical Trials and Drug Safety Systems
• Quality Management Software (QMS)
• Prospective and Retrospective Validation, Re-Validation
• Validation Staffing and CSV training
• Validation Documentation including Validation Master Plan,
IQ/OQ/PQ, Traceability Matrix, Summary Reports
• GAP Analysis and Risk Assessments
• Lab Systems: HPLCs, LCMSMS, Scientific Data base Management
System, Bio-analytical LIMS.
6RSServe Confidential

7. Services – GMP audits
• QMS implementation and gap analysis
• Good Manufacturing Practice reviews
• Quality audits of manufactures, suppliers, distributors and
contractors of both sterile and non­sterile APIs and Finished Drug
Products
• Process validation, analytical validation and equipment qualification
• Quality Assurance and Quality Control operational support
• Regulatory inspection readiness preparations
• Documentation design, generation and maintenance support
• Quality Risk Assessment and mitigation support
• Training of staff in areas of Pharmaceutical manufacturing both
aseptic and non­aseptic
• Clinical manufacturing and packaging.
7RSServe Confidential

8. Services – Other services
• Training:
– SOPs, GCP (for CROs, Investigators and Coordinators, CRAs and
clinical trial managers)
– Computer System Validation
– GCP auditing skills
– Regulatory Inspection Preparedness
• Mock Inspection:
– Mock GCP Regulatory Inspections
– Investigative Site Training and Preparedness
– In process Inspection Support and Facilitation
– Response creation
• SOP Development and Management:
– Process Assessment and Mapping (Flow Chart)
– Gap Analysis
– SOPs Development and Administration.
8RSServe Confidential

9. Procedural documents
• SOP BABE­001­01, Monitoring of BA/BE Studies
• SOP CORP­001­01, Standard Operating Procedure (SOP)
Management
• SOP QA­001­01, Audit Report Preparation, Distribution and
Corrective and Preventive Action Implementation
• SOP QA­002­01, Vendor Audit
9RSServe Confidential

10. Contacts
www.rsserve.in
Thank You
10RSServe Confidential
Mr. Hitesh Shah
Tel: +91 9821218347
Email: hiteshs@rsserve.in
Mr. Bipin Patel
Tel: +91 9819197022
Email: bipinp@rsserve.in