Copper taurus R&D and Technology Consulting services

Colorado | Dallas | Charlotte | Hyderabad | Mumbai www.coppertaurus.com Confidential
Company Overview
CopperTaurus Technology & Consulting services help its clients transform their
business management, operations and customer engagement by leveraging our
industry-wide experience and deep technology expertise to improve their
performance and competitive positioning. Our next generation services in Internet of
Things enable clients to think ahead of innovation curve and stay there.
Our Centers of Excellence are an integration of strategic technology and consulting
practices with a vision of continuous innovation & research to provide insights on
what’s next. We enable clients to unlock their enterprise potential and renew
themselves to offer fresh customer experience. We are well positioned to standardize
client’s business management and operational leadership through co-creation of
cloud integrated web and mobile solutions.
CopperTaurus is perfectly placed to partner with clients in their transformation plan
to harness growth opportunities and creating new avenues to generate value.

Pharmaceuticals
& Drug Supply
Industries

Pharma & Drug Supply Consulting
CopperTaurus guides and helps blueprint a technology driven R&D roadmap for
pharmaceutical and drug manufacturers to become more competitive and successful
in a rapidly evolving market. We help streamline costs in the face of increasing price
pressure. Our analytical capabilities are leveraged to enforce a data driven decision
model to predict, measure and fix the outcomes. CopperTaurus pharma scientists
provide technical input and advice to help clients improve their product and
packaging.
Nothing should get between you and the market. Accelerate your R&D with our
Center of Excellence comprised of Pharma R&D experts and technology industry
professionals. We understand your challenges and help you build sustainable world
class solutions that can directly affect your bottom-line.

Industry Challenges
Pharmaceuticals & drug suppliers are operating in increasingly competitive markets under high
and ever changing regulatory & compliance requirements. Despite ongoing medical need related
to many diverse diseases, companies can no longer depend only on their innovation engines and
pricing power to achieve profitable growth. Ongoing cost pressures and a steady decline in R&D
productivity results in a considerable decline in overall profits.
The critical question for these companies is how to optimize their business operations and invest
in R&D to thrive in a world of shifting profit pools.

Pharmaceutical
manufacturers are
operating in increasingly
competitive markets
under high and never
satisfying regulatory and
compliance requirements.
Continuous Research &
Development to keep
meet markets needs with
diverse diseases and
increasing operating costs
of manufacturing
facilities.
Thinly focused too
many Research &
Development projects
poorly aligned with
company long term
strategy.
Industry Challenges

Too many processes
that are not
consistently followed
consequently not
delivering value but
incurring costs.
Too many point
contacts and decision
makers in the process
without a streamlines
approval system.
Distributed manufacturing
and administrative facilities
without centralized
communication system and
too little control over them.
Industry Challenges

Center of Excellence (CoE)
CopperTaurus 360⁰ Center of Excellence can be plugged into client company independently, or
in conjunction with existing projects and teams. Our consulting programs are customizable
based on client requirements and support companies ranging from startups to large corporates.
In addition, services can be provided in-house, on site at multiple client locations or at third
party facilities.
Technical | Research &
Development Consulting
Compliance & Regulatory
Consulting
Project Management Office Integrated Technology
CopperTaurus
Centers of
Excellence

CoE – Technical | R&D Consulting
❶ Formulation | Preformulation and formulation development.
❷ Analytical Techniques | High Performance Liquid Chromatography (HPLC) , Liquid
Chromatography – Mass Spectrometry (LC/MS), Gas Chromatography-Mass
Spectrometry (GC/MS), Ultraviolet-Visible Spectroscopy (UV-Vis).
❸ Analytical Equipment Validation | Installation Qualification (IQ), Operational
Qualification (OQ), Performance Qualification (PQ).
❹ Stability | Stability-indicating method development, validation and transfer.
❺ Planning| Validation master plan development.
❻ Protocol | Stability protocol development.
❼ Documentation| Common Technical Document (CTD) module#3 planning and
preparation.
❽ Strategy| Cleaning validation and verification strategy.

CoE – Project Management Office
❶ Plan| Clinical study protocol based Clinical Supply Plan.
❷ Request for Proposals (RFPs) | Manufacturing, Testing, Packaging, Labeling,
Distribution Contractors.
❸ Budgets| Research & Development central long term and short term budget
projections. Tracking and reporting actual expenses as being incurred.
❹ Vendor Screening, Selection & Management | Releasing RFPs based on R&D
requirements, reviewing contractor quotes, vendor profiling based on 5 level
screening, on-site audits and engagement management.
❺ Project Management| Leading, tracking and reporting R&D projects against
timelines.
❻ Inventory Management | Monitoring drug supply inventory at contract packager.
❼ Packaging & Labeling| Designing patient and site compliant packaging and labeling
❽ Operations| Plan, implement, track and report work with analytical laboratories,
contract manufacturers and contract packaging operations.
❾ Returns| Monitoring returns, reconciliation and destruction of supplies.

CoE – Compliance & Regulatory
❶ Compliance| 21 Code of Federal Regulations (CFR) Part 11
❷ Good manufacturing and laboratory practice, Reference Standard Management
❸ OOS, root cause investigations, CAPAs
❺Regulatory | CMC strategic guidance for development and commercialization of
products
❻Support regulatory dossier preparations for NDAs, INDs, IMPDs, health authority
submissions and subsequent response to health authority questions
❼Documentation| Statement of Purpose (SOP), Quality manual, Validation and CMC
stability summary reports, quality frame agreement for third party management
❹ Health, safety and environment management by optimizing balance between reputation,
minimum acceptable risk and costs

CoE – Integrated Technology
CHANNEL
CRM
CORE PROCESS
CONSULTING
BUSINESS
MANAGEMENT
MOBILE WEB
ORDER MANAGEMENT PARTNER MANAGEMENT
FIELD SERVICE ANALYTICS SALES MARKETING
E-TRAINING
STRATEGY &
GOVERNANCE
PROCESS DESIGN &
IMPLEMENTATION
PROCESS AUTOMATION &
TECHNOLOGY SOLUTION
OPERATIONS
MANAGEMENT
BUSINESS
INTELLIGENCE
SENSORS
R&D COMMERCIAL MANUFACTURING SUPPLY CHAIN
PoC CLINICAL TRIALS CUSTOMER SATISFACTION

Agility | Adaptability | Technology
We work closely with our clients to untangle their complexity and install a clear and
concise, repeatable technology enabled R&D process. CopperTaurus Agility
Adaptability and Technology model is applied to achieve a technology driven lean
innovation R&D.
Agility
Understand clients R&D
processes and enabling
tools.
Build short term and
long term innovation
roadmaps coupled with
optimization roadmap.
Adaptability
Streamline R&D process
to improve time-to-
market, cost and quality.
Build continuous
learning systems and
supporting processes to
train and adapt.
Technology
Track and monitor team
performance.
Optimize resources and
process flows.

www.coppertaurus.com
.
Vision | Ethics | Expertise | Commitment
.
ananth@coppertaurus.com
+91 984 947 6365
Get
in touch.

Copper taurus R&D and Technology Consulting services

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