Pharma / Healthcare

With tremendous pressure from shareholders, regulators & customers, the pharma and life sciences firms are going through more difficult times than ever. Challenges facing the industry are aplenty-from low margins, competition from generics, long development times, thinning pipelines and a greater regulatory burden, the industry is most challenging of sorts.

Challenges - Offerings

Regulatory Requirements

21CFR Part11 Practice

Our 21 CFR Part 11 practice spans all functional areas within a pharmaceutical or a biotechnology corporation. We can develop a corporate wide strategy and implement it at a facility level. Our engagements have taken us through almost all facets of 21CFR Part 11.

Some of our specific offerings pertaining to 21 CFR Part 11 are:

	Corporate-wide Planning Strategy
	Interpretation
	Gap Analysis
	Risk Analysis
	Remediation Planning
	Product Capability Analysis

GMP/GLP/GCP (GXP) Compliance Practice

Under our GMP/GLP/GCP (GXP) practice, we offer the following services to our clients.

	Develop Validation Plans and Project Plans
	Evaluate Technology and Vendors
	Perform Vendor Audits
	Develop Software Quality Assurance Plans
	Develop User Requirements, Functional Requirements, System Specifications
	Perform Design and Code Reviews
	Perform Risk Analysis
	Support Development, Installation and Commissioning
	Implement Unit and Integrated System Testing
	Implement Factory / Site Acceptance Testing (FAT / SAT)
	Develop and Implement IQ, OQ and PQ Protocols
	Develop Traceability Matrices
	Develop Policies and Procedures (SOPs)
	Perform Systems Optimization

Collaboration

Bring together your R&D, Manufacturing & Sales/Marketing force to collaborate real-time to cut project/production times drastically and reduce the cycle time of the drug to market.

Content / Document Management

We have partnered with some of the best in Content Management to bring whole suite of functionalities like-Documentum Management, Web Content Management, Business Process Management including workflows, Digital Asset Management, Records Management, OCR etc. With years of experience in Content management technologies we are rightly positioned to achieve your vision of managing your data most efficiently and realize your ILM strategy goals with quick ROI and low TCO.

Business Intelligence

Shortage of Competent Resources

Trust us on your most important asset. We offer you complete flexibility of hand picking competitive technology resources and deploying them at the shortest lead time. Our Best Shore development centre offers you the flexibility of carrying out non critical development work at the fraction of cost to lower the total cost of development and ownership of an application.

Why Verinon - Our Differentiators

	With over 1200 + person years of Pharma/Lifesciences domain experience we understand the issues faced by you better than anybody else
	ISO 9001 certified & Cmmi Level 3 approved quality processes
	Big enough to execute large scale projects & small enough to be flexible and focus on your needs
	Partnerships/Tie up’s with Industry’s leading players like EMC, Microsoft, Informatica, Business Objects, Tibco, Google
	Global presence - US, Europe, Asia Pac with Best Shore facility in India