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.

Vinnakota, Harsha

insights on the road ahead.

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 Office❶ 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 | TechnologyWe 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

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+91 984 947 6365

Get in touch.


copper taurus r&d and technology consulting services

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