1. Speed | Innovation | Happiness
Quality & Regulatory Overview

2. Speed | Innovation | Happiness
Quality Policy
Team Bilcare is committed to offer a wide range of Innovative Services
to the Global Pharmaceutical Industry that includes
Clinical Trial Manufacturing, Packaging Design and Development, Labeling,
Sourcing of Innovator Drug Products, IVRS/IWRS
and Storage & Distribution of Investigational Medicinal Products.
Our endeavor is to provide Credible, Safe, User-friendly, Cost effective and
Creative Solutions for ‘Clinical Trial Material Supplies’ Business,
together with the Strategic Partners and are aimed at our Customers’ Success.
Our focus on Customer Satisfaction through Consistency in Quality,
Cost and Service Standards is benchmarked against the Global best.
Excelling through continual Self Improvement is a way of life at Bilcare.

3. Speed | Innovation | Happiness
Quality Management System
Quality Management System’s in compliance with:
cGMP: current Good Manufacturing Practices
GCP: Good Clinical Practices
GDP: Good Documentation Practices and Good Distribution Practices
GWP: Good Warehouse Practices
ISO 9001; 2008 – QMS Requirements
Annexure 13 of Orange Guide: Manufacture of Investigational Medicinal Products, EU
21 CFR part 11
PIC/S GMP Guide
Schedule M and Y: Drugs and Cosmetic act 1940 & Rules 1945, India

4. Speed | Innovation | Happiness
Documentation Levels
Quality
Manual & SMF
VMP & SOPs
Flow Charts, Specifications
Records & Formats

5. Speed | Innovation | Happiness
Roles and Responsibilities of Quality
Documentation
Management
Quality Systems
Area / Equipments /
Instruments Control
Inspection
Monitoring Batch Releases Training
Audits – Internal/
External /Vendors

6. Speed | Innovation | Happiness
Few important SOPs in QA
Management of
SOPs
SOP Archival
Good
Documentation
Practices
Deviation control
Change control
system
Complaint handling
Management of
Corrective and
Preventive Actions
Quality Risk
Management
Environment
Monitoring
Batch Release
Training
Self inspection/
Internal Quality
Audits

7. Speed | Innovation | Happiness
Continual Improvements
Implementation of Systems
through learning from
various internal and external
audits
Improvements on weak areas
identified from Customer
feedback and complaints; and
strengthening the core areas
Working on points for
Improvements after every
Management Reviews &
MIS meets
Improve knowledge base of employees
through various Internal and External
Trainings, Reading, Participation in
Seminars and Conferences. Investing avg.
80 hours of training per person per year
Effective Communication & Co-
ordination with Employees,
Management, Vendors, Service
Providers & Customers to
reduce any gaps

8. Speed | Innovation | Happiness
Certification & Licenses
Local Drug Regulatory Approvals
(Licenses PD-191/25 and PD-113/28, valid up-to 16th Sept 2018)
GMP Certificate issued by Local regulatory body valid up-to 16th Sept 2018
ISO 9001:2008 certified , valid up-to 18th June 2016
Scope (ISO 9001:2008)
Design of Packing for Investigational Medicinal Products
Sourcing of Innovator Drugs
Packaging, Labeling, Storage and Distribution of IMP’s and Innovator Drugs

9. Speed | Innovation | Happiness
ISO & GMP Certificates

10. Speed | Innovation | Happiness
Local Drug Regulatory Approvals
Licenses PD – 191/25 & PD – 113/28, Valid till 16th Sept 2013
New Images

11. Speed | Innovation | Happiness
Local Drug Regulatory Approvals
Storage & Distribution License – Form 20B & NDPS License (Controlled Substances)
New Images

12. Speed | Innovation | Happiness
Knowledge & Expertise
Regulatory Guides across the Globe
cGMP, GMP, GDP, GLP and GCP
Keeping eye on current updates on clinical trial regulation
Scientific & Legal Expertise to find legal solutions
Assurance of meeting timelines with Efficient & Effective way of handling projects
Value additions in terms of cost & technical aspects
Expert Staff - Pharma Graduates & Post Graduates, Microbiologist and Doctorates
Acquire & Develop the required Regulatory management skills for driving
Clinical Trials effectively and become One Stop Shop for the CROs and Sponsors

13. Speed | Innovation | Happiness
Regulatory Support Services
Global Clinical Trials Phase II to IV
BA/BE (Bioavailability and Bioequivalence) studies
Controlled Drug substances approvals from Central Bureau of Narcotics and State authorities
Drug Import & Export Licenses
Site endorsement and transport permit for NDPS
Shipping & Transportation Regulation
QP Audit & Batch Release Services
Liaison services with Central & State Authorities for following

14. Speed | Innovation | Happiness
Offers Expertise in Regulatory submissions through technical domain experts
Review of Multiple documents generated before, during, & after Clinical Trials
Value additions in Study Protocols as per regulatory standards
Experience in Harmonized data in terms of content & customized format – reducing review
time & duplication
Investigator’s Brochure
Clinical Trial Applications (Protocol, Ethics Committee, Amendments etc.)
Import & Export Permissions (Investigation & Comparator Drugs, Reagents etc)
Global Regulatory Services

15. Speed | Innovation | Happiness
www.bilcareGCS.com
“Experience Bilcare - Experience World Class Services”
Chhanda Das
Vice President- QA & Regulatory
chhanda.das_gcs@bilcaregcs.com
Mob: + 91 992 240 8512
Bilcare Global Clinical Supplies
1028, Shiroli, Rajgurunagar, Pune- 410505. India
Tel: +912135 304406 | Fax: +912135 304417