RMS - Regrow gets GMP, GLP & GCP certification

RMS - Regrow gets GMP, GLP & GCP certification

Announcement / Corporate September 14, 2011, 20:01 IST

Regenerative Medical Services Pvt. Ltd. a Under GMP guidelines, all critical processes
leading Biotechnology company in India are validated to ensure consistency and
focused on the delivery of the most compliance with specifications. GMP are the
advanced Stem Cell therapy treatment, systems required to be adapted in
received the 3 major certifications, Good development, quality control, quality system
Manufacturing Practices (GMP), Good covering the manufacture and testing of
Laboratory Practices (GLP) and Good medical therapies & drugs including active
Clinical Practices (GCP) from the pharmaceutical ingredients, diagnostics,
International Accredited Body - BSI (British pharmaceutical products, and medical
Standard Institution). devices.

The GMP, GLP and GCP certifications Good Laboratory Practice (GLP) is a
received by RMS-Regrow® are recognition system, which has been evolved by
from an approved international body which Organization for Economic Co-operation
validate the procedures adopted and and Development (OECD) used for
followed at RMS-Regrow®. These establishing non-hazardous nature of
certifications place RMS Regrow® in the company products wherein the laboratory
select league of companies that have been studies are planned, performed, monitored,
awarded such a global honor. It is a matter recorded and reported. GLP practices are
of National pride for the company not only intended to promote the quality and validity
to be involved in the commercial delivery of of test data. National GLP Compliance
Cellular Therapies & Stem Cell Banking, Monitoring Authority was established by the
but also to be internationally recognized for Department of Science & Technology,
the same. Government of India, with the approval of
the Union Cabinet on April 24, 2002.
“This is a landmark achievement for us as
this certification has come within the first Good Clinical Practice (GCP) is an
two years of the company’s operations since international quality standard that is
September 2009 after receiving its ISO provided by International Conference on
13485:2003. This significant milestone Harmonization (ICH), an international body
enables the company to advance the global that defines standards, which governments
commercialization of cellular therapies, live can transpose into regulations for clinical
up to the commitment of exceeding trials involving human subjects. It also
customer expectations and maintaining provides assurance of the safety and efficacy
manufacturing excellence” said Dr. Satyen of the newly developed compounds. Good
Sanghavi, Chief Scientific Officer at RMS. Clinical Practice Guidelines include
standards on how clinical trials should be
Good Manufacturing Practice [GMP] is a conducted; define the roles and
regulatory requirement that is recognized responsibilities of clinical trial sponsors,
worldwide for sound quality principles. clinical research investigators, and monitors.

Bio Technology Policies Story

RMS - Regrow gets GMP, GLP & GCP certification

Mumbai, Sep 19, 2011: Regenerative Medical Services, a leading Biotechnology company
in India focused on the delivery of the most advanced Stem Cell therapy treatment,
received the 3 major certifications , Good Manufacturing Practices (GMP), Good Laboratory
Practices (GLP) and Good Clinical Practices (GCP) from the International Accredited Body -
BSI (British Standard Institution).

The GMP, GLP and GCP certifications received by RMS-Regrow are recognition from an
approved international body which validate the procedures adopted and followed at RMS-
Regrow. These certifications place RMS Regrow in the select league of companies that have
been awarded such a global honor. It is a matter of National pride for the company not only
to be involved in the commercial delivery of Cellular Therapies & Stem Cell Banking, but
also to be internationally recognized for the same.

"This is a landmark achievement for us as this certification has come within the first two
years of the company’s operations since September 2009 after receiving its ISO
13485:2003. This significant milestone enables the company to advance the global
commercialization of cellular therapies, live up to the commitment of exceeding customer
expectations and maintaining manufacturing excellence" said Dr Satyen Sanghavi, Chief
Scientific Officer at RMS.

Good Manufacturing Practice [GMP] is a regulatory requirement that is recognized
worldwide for sound quality principles. Under GMP guidelines, all critical processes are
validated to ensure consistency and compliance with specifications. GMP are the systems
required to be adapted in development, quality control, quality system covering the
manufacture and testing of medical therapies & drugs including active pharmaceutical
ingredients, diagnostics, pharmaceutical products, and medical devices.

Good Laboratory Practice (GLP) is a system, which has been evolved by Organization for
Economic Co-operation and Development (OECD) used for establishing non-hazardous
nature of company products wherein the laboratory studies are planned, performed,
monitored, recorded and reported. GLP practices are intended to promote the quality and
validity of test data. National GLP Compliance Monitoring Authority was established by the
Department of Science & Technology, Government of India, with the approval of the Union
Cabinet on April 24, 2002.

Good Clinical Practice (GCP) is an international quality standard that is provided by
International Conference on Harmonization (ICH), an international body that defines
standards, which governments can transpose into regulations for clinical trials involving
human subjects. It also provides assurance of the safety and efficacy of the newly
developed compounds. Good Clinical Practice Guidelines include standards on how clinical
trials should be conducted; define the roles and responsibilities of clinical trial sponsors,
clinical research investigators, and monitors.

RMS Regrow bags 3 major certifications
from international accredited body, BSI

Our Bureau, companies in the world manufacture and testing of
Hyderabad Thursday, September complying with standard
15, 2011, 08:00 Hrs [IST] procedures that are approved medical therapies & drugs
international body. There are
very few companies in India that including active pharmaceutical
have acquired such standards in
quality especially in the ingredients, diagnostics,
commercial delivery of Cellular
Regenerative Medical Services Therapies & Stem Cell Banking. pharmaceutical products, and

(RMS) Pvt. Ltd. a leading “This is a landmark achievement medical devices.
for us. It will enable us to
Biotechnology company in India advance the global For Economic Co-operation and
commercialization of cellular
has bagged 3 major therapies, live up to the Development (OECD) used for
commitment of customer
certifications, Good expectations and maintaining establishing non-hazardous
manufacturing excellence” said
Manufacturing Practices (GMP), Dr Satyen Sanghavi, chief nature of company products
scientific officer at RMS.
Good Laboratory Practices GLP has become an important
In the present context of global
(GLP) and Good Clinical business, Good Manufacturing criterion to be followed by the
Practice [GMP] is an important
Practices (GCP) from the regulatory requirement for the organizations. GLP system has
medicine manufacturing firms.
International Accredited Body - It gives them worldwide been evolved to perform
recognition for their quality
BSI (British Standard products. Under GMP planned laboratory studies,
guidelines, all critical processes
Institution). are validated to ensure check performance, monitor
consistency and compliance
with specifications. GMP are the records and reports. GLP
systems required to be adapted
RMS Regrow’s main focus is in development, quality control, practices are intended to
delivering Stem Cell therapy quality system covering the
treatment. It is the only promote the quality and validity
company in India which is
conducting research on of test data.
advanced cell therapy treatments
and Cord Blood Banking GCP is an international quality
(Babycell). Through its Stem standard that is provided by
Cell Processing Centre, the firm International Conference on
offers autologous cartilage and Harmonization (ICH). It also
bone cell therapeutics to provides assurance of the safety
patients. It also aims at applying and efficacy of the newly
regenerative medicines to bring developed compounds. Good
effective patient specific Clinical Practice Guidelines
therapeutics to bed side. include standards on how
clinical trials should be
With the GMP, GLP and GCP conducted; define the roles and
certifications, RMS Regrow is responsibilities of clinical trial
placed in the select league of sponsors, clinical research
investigators, and monitors.

RMS - Regrow gets GMP, GLP & GCP certification

Mumbai, September 14, 2011 – Regenerative Medical Services Pvt. Ltd. a leading Biotechnology company in India focused on
the delivery of the most advanced Stem Cell therapy treatment, received the 3 major certifications , Good Manufacturing
Practices (GMP), Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) from the International Accredited Body - BSI
(British Standard Institution).

The GMP, GLP and GCP certifications received by RMS-Regrow® are recognition from an approved international body which
validate the procedures adopted and followed at RMS-Regrow®. These certifications place RMS Regrow® in the select league of
companies that have been awarded such a global honor. It is a matter of National pride for the company not only to be involved
in the commercial delivery of Cellular Therapies & Stem Cell Banking, but also to be internationally recognized for the same.

“This is a landmark achievement for us as this certification has come within the first two years of the company’s operations
since September 2009 after receiving its ISO 13485:2003. This significant milestone enables the company to advance the global
commercialization of cellular therapies, live up to the commitment of exceeding customer expectations and maintaining
manufacturing excellence” said Dr. Satyen Sanghavi, Chief Scientific Officer at RMS.

Good Manufacturing Practice [GMP] is a regulatory requirement that is recognized worldwide for sound quality principles.
Under GMP guidelines, all critical processes are validated to ensure consistency and compliance with specifications. GMP are
the systems required to be adapted in development, quality control, quality system covering the manufacture and testing of
medical therapies & drugs including active pharmaceutical ingredients, diagnostics, pharmaceutical products, and medical
devices.

Good Laboratory Practice (GLP) is a system, which has been evolved by Organization for Economic Co-operation and
Development (OECD) used for establishing non-hazardous nature of company products wherein the laboratory studies are
planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test
data. National GLP Compliance Monitoring Authority was established by the Department of Science & Technology, Government
of India, with the approval of the Union Cabinet on April 24, 2002.

Good Clinical Practice (GCP) is an international quality standard that is provided by International Conference on Harmonization
(ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials
involving human subjects. It also provides assurance of the safety and efficacy of the newly developed compounds. Good
Clinical Practice Guidelines include standards on how clinical trials should be conducted; define the roles and responsibilities of
clinical trial sponsors, clinical research investigators, and monitors.

About RMS - Regrow®

RMS Regrow® is a leading biotechnology company in India, focused on advanced cell therapy treatments and Cord Blood
Banking (Babycell). Through their SCPC (Stem Cell Processing Centre) – the only one in India, RMS Regrow® offers autologous
cartilage and bone cell therapeutics to patients. RMS Regrow® aims at applying regenerative medicines to bring effective
patient specific therapeutics to bed side. The treatments are now available at various hospitals across India. A synergy between
the hospitals, clinicians and RMS - Regrow® is anticipated to bring a health boom in India. Patented and successfully practiced,
these therapies are destined to change the outlook of health industry. Currently focusing on its expertise, RMS - Regrow® is
involved in the following services:

Autologous Cartilage Regeneration Therapy (ACI)- Chondron™
· Autologous Bone Regeneration Therapy (ABI)- Ossron™
· Umbilical Cord Blood Banking – Babycell™
· Wound & Pain Management