GSR PHARMA

CORPORATE

OVERVIEW

AGENDA

GSR Pharma Corporate Overview

Capabilities & Portfolio

Research & Development solutions portfolio

Clients & engagement

Regulatory Audit & Compliance solutions

Analytical R&D solutions portfolio

Introduction - Founder & Managing Director

29 Years of Rich

Experience in

Pharma R&D,

Business

Development &

Production

Management

Track Record of several formulations development &

more than 150 ANDA’S, Developed & acquired patents

for Para-IV and first to file products

Held key positions & responsibilities, contributed to growth in regulated

markets by not only expanding in technology of products but also revenue

and profitability growth in emerging markets & across globe

• Divisions & Departments

• Research & Development, Regulatory & compliance

• Business development & marketing

• Production management

Companies:

• Dr. Reddys Laboratories, India –R&D Head

• Zydus Cadila, India –General Manager

• Hikma Pharmaceuticals PLC, Jordan - Senior Vice President

• Mid pharma & Promed Research - Global R&D Head

• Parabolic Drugs Ltd, India - President

• GVK Bio Sciences, India - Business Head

Introduction - Founder & Managing Director (contd..)

Business partnership, Member, Guest Lectures & Conferences Industrial member to train the Jordan FDA staff on Industrial related and BE studies &

challenges

Given guest lectures in different workshops and universities:

Like invited by the Vision Gain center in London to deliver talk on

“ Bigeneric product development”

Delivered as main speaker in International conference in Jordan

Several talks delivered in Manipal university and also Couple of Universities in Bangalore

Business Partnership & Collaboration:

Traveled and established business contacts in USA, Europe, Middle East, Brazil, Turkey,

Malaysia and other countries

contributed in technical discussions and for Regulatory Submissions.

Faced many USFDA Inspections and also other regulated markets audits like MHRA,

EMA ,TGA, GCC etc.

Rich experience in developing robust systems and processes to meet regulatory

markets requirements

Purpose & Overview of GSR Pharma

GSR Pharma founded in 2017

• Managing director

• Business Development Manager - 1

• Research scientists : 25

• HR, Finance and accounts – 2

Present

structure of

GSR Pharma

Purpose & Values :

Mission :To develop and create unique talented scientists in Research and

Regulatory space to generate 500 + employment opportunities in meeting

the industry demands

Vision : Redefine the Research & Development space in Pharma , provide out of the

Box Ideas, solutions and services inline with growing Regulatory and

compliance requirements across Globe

What Makes GSR Pharma different & unique

Rich

experience in

R & D , in

products as

well as in

services

companies

Provide

Services &

solutions out

of box and

first of its kind

Can tap the

areas to

address the

FDA audit

findings &

expectations

Can help in

identifying

right

molecules &

business

development

Support in

cost effective

operations in

R&D and

production

New R&D and

AR&D Setup

Cost effective

BE Studies

design with

proactive

approach &

methodology

Generic

Business &

Submissions

Strategy

across globe

GSR Pharma Capabilities and competencies

R&D capabilities

• Pre-formulation development

• Formulation Development

• Re-formulation of existing

products

• Bio-equivalence Study design

• Cost effective product

development

AR&D capabilities

• Analytical method development

• Analytical method validations

• Stability studies

• Data Reviews

Regulatory Services

• Regulatory compliance support

• Pre-Audit and post audit

assistance

• ANDA filing strategy

• Document & data review

• Quick solutions for USFDA audit

findings / challenges

Setting up New Facilities

• New R&D facility

• New pilot plant

• New AR&D facility

• New production facility

Our capabilities and services port folio

Competency to develop the first entry complex generic products

Development expertise of 505b2 formulations

Significant experience of interaction with regulatory bodies (USFDA, MHRA , TGA, MENA regulatory, Malaysian etc.)

Country specific expertise in Intellectual Properties, dossier development and regulatory filings

Expertise of handling products with difficult Bio-Equivalence profiles

Conducting breakthrough research and overcoming formulation difficulties

Providing cost advantage to partner without compromising the product quality

Access to a wide range of accredited manufacturing network

Expertise in technology transfer and troubleshooting during scale up process

Very good BD and leadership skills

Core Expertise

Research &

Development

Portfolio

Investigation of Failure of bio-studies

Failure of Dissolution profile comparison against innovator

Failure of assay during stability studies

Failure of impurity limit during stability studies

Overall product lifecycle management

Self Life Extension

Commercial batches process validation and tech transfer

R&D a challenging space for pharma innovation

Intrinsic Dissolution

Container Closure Interactions

Drug/Excipient Compatibility study

Physical properties: particle size, flow-ability, compressibility, bulk & tap density

Solubility studies (aqueous, non-aqueous, FaSSIF, FeSSIF, & SGF mediums)

pH-Solubility profile

Impact of Particle Size on Dissolution

Log P/Log D

Leechables & Extractables

Crystalline Properties (X-Ray Diffraction Studies)

Solution State and Solid State Stability Studies

Chiral Resolution & Screening

Salt Screening & Polymorph Screening

Hygroscopicity Studies

R&D Pre-formulation service port folio

Preformulation Development

Formulation Development

Reformulation

Preclinical and Clinical Supplies

Analytical R&D

Stability studies

Exhibit batch manufacture

ANDA/Dossier Development

Contract Manufacturing (3rd Phase)

Differentiators• Strong pre-formulation development strategy which is useful to

rectify future possible issues related to stability and troubleshooting

• Develop and scale-up of high potent formulations (as low as 25 micro gram per tablet) using direct compression process

• Expertise in taste masking of oral solid dosage forms

• Designing and generating multimedia dissolution profiles for a successful BE study

• Expertise in design, planning and execution of process validation and technology transfer

• Strong regulatory awareness and interactions with USFDA and EU authorities

Formulations R&D – Complete Spectrum of Work

Re-formulation of Existing Products

• For improvement of BE Study,

• Improvement of dissolution profile matching against innovator profile

• Improvement of stability data of assay and Impurity

• Improving manufacturing process for reduction in cost and process time

Develop In-vitro dissolution design in a manner to obtain Bio-waiver for solid dosage forms

Investigation of Bioequivalence failures by interpreting in-vitro and in-vivo data for the success of pivotal studies

Designing of Bio-equivalence Studies

Analytical Research &

Development

Portfolio

Our focus areas for Method

Development

• We focus on method Robustness analysis – Performed as integral part of method development. Where we assure that method will withstand minor deviations

• Signal Response Factor – Critically studied during method development to establish calculation for multiple related substances thus saving costly impurities in routine operations/analysis

• Pre- validation performance parameters are studied to avoid surprises during validation

AR&D Services – Method Development & Validation

Method Development &

Validation

• Assay• Related Substances• Particle size distribution• Residual Solvents• Antioxidants• Preservatives• Potentiometric methods

Objective for Method Transfers

• Specificity • Robustness• Signal response factor• Preliminary validation• Forced degradation • Precision• Linearity and LOQ, Accuracy

Regulatory Affairs

Service Portfolio

Regulatory contribution beyond the guidelines

Cumulative experience of the filing over 150 ANDAs (including Para IV strategy) & dossiers, meeting global regulatory requirements

Strong regulatory awareness and interactions with USFDA and EU authorities with good convincing capabilities along with strong scientific supporting backup data

Scientifically designed product specification with five point criteria.

Patent circumventing and filing of para-IV and response to all regulatory deficiencies for expediting the Regulatory approvals and launching of new products on time .

Regulatory Frame work & compliance services

Compliance support – Out of Box solutions

DATA Integrity and Electronic data management queries

(Instrumental connectivity for automated software's )

Data review and identification of gaps if any

OOS handling and performing route cause analysis

Improving impurities on stability if required

Complete review of all analytical data and making reports by using different software’s

To improve dissolution profile data - identification of gaps in formulation/manufacturing process/analytical methods etc

Quick solutions for USFDA findings & challenges

(FTE Business)

GSR Pharma

Business Models

Formulation Development

• New R&D Setup

• New Scale-up / Pilot facility Setup

• Development of different dosage forms (SR, MR, DR, Palletisation etc.) and finalization of technical strategy as per regulatory requirement

• Development of the product in the existing labs up to advance stage

• Transfer of technology to the client site for scale up

• Assistance in manufacturing scale up batches and pivotal BE studies

• Responding regulatory queries related to development

Analytical Development

API & Formulations

• New AR&D Setup

• Small molecule testing

• Method development and validation for DS & DP

• Stability and photo stability as per ICH

• Quality control and release testing

• Raw material and compendia testing

• Physicochemical characterization

• Comparative Dissolution Profiling

Solutions to FDA findings FTE Business

API & Formulations

• Understanding the real FDA findings and actions suggested

• Workout the strategy to respond FDA queries

• Workout the total work load involved and type of work

• Work out the timelines considering the amount of work

• Provide the FTE quote along with the scope of work .

Business Models

Present Client Engagement

GVK BIO sciences, Hyderabad- For formulation development and business consultancy (completed)

Apotex, Bangalore 150 FTEs business to support FDA audit responses ( completed successfully )

Presently Ipca FTE support is on going with20 FTEs and expansion request from March 2019

Present Client engagement & Collaboration

Apotex and Ipca Laboratories FTE business Other collaborations in Progress

FTE business model under discussion with Dr. Reddy’s, Divis Labs, Strides and two more companies in India.

Formulation and Analytical development model under discussion with couple of companies out side India

Setting up an R&D lab, product development and tech transfer model under discussion with one international company.

ANDA development strategy consultancy for Injectable products for Bangalore company

THANK YOU