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INDUSTRY > Life Sciences
Companies in the Life Sciences industry continuously face the challenge of complying with a wide and expanding body of laws and regulations including the numerous requirements of the global regulatory agencies such as the FDA, EMEA and JMHLW. The rigorous regulatory environment, the fast changing pace of scientific discovery, and increasing availability of more capable and increasingly costly technologies add to the challenges of bringing a drug or device to the market.
  Key Industry Issues:
  Mergers and Acquisitions
  Regulatory Pressures
  Globalization
  Competition/Patent Protection
  Time to Market –Integration of R&D, Manufacturing and Marketing
  Filling the R&D Pipeline Cost of R&D
  Increased Customer Expectations
  Softening Margins/Downward Pricing Pressures
Every segment of this industry is feeling the pressures of increased competition, privacy laws, corporate governance and consumer protection laws and ever demanding customers. Though ERP applications help companies integrate the core manufacturing processes and enable better compliance, the industry is still faced with the newer challenges of maintaining these systems while integrating the Research and Development and Quality functions into the ERP platform without compromising on compliance.

Intelligroup’s Global Life Sciences practice brings its rich domain expertise, ERP experience and in-depth knowledge of global regulatory compliance requirements to develop and deliver an integrated set of solutions and services for large as well as small and medium companies in the pharmaceutical, bio-pharmaceutical and medical devices segments.

  Key Differentiators:
  Domain expertise
  ERP and compliance/validation expertise
  Global presence with experienced consultants available with knowledge and expertise on global and local regulatory and compliance needs
  Cost-effective adaptive Global Delivery Model
  Rapid deployment solutions for small and midsize companies in Pharma, Bio-Pharma and Medical Device segments
Intelligroup provides a wide variety of services including assessments, fit-gap analysis, scope evaluations and new functionality reviews, building proof of concepts, enterprise lifecycle management services, compliance services and implementation services covering global rollouts, local implementations, rapid deployment of solutions and hosted solutions from a fully compliant, state-of-the-art data center.
Intelligroup provides value-added solutions and services to address the needs of companies in the Life Sciences industry across Research and Development through commercial manufacturing and distribution. These services include:

 
Rapid deployment of industry solutions enabling higher level of compliance for small and medium-sized companies – Pharma Express
 
Range of solutions to address the needs of Clinical Management (Clinical Trial Management, Clinical Trial Supplies Management, Clinical Data Management) including randomization and labeling solutions integrated with ERP and IVRS systems
  Enterprise LIMS management solutions
 
Solutions to enable compliant manufacturing addressing the cGxP needs of the industry including EBR solutions with Electronic Records/Electronic Signatures and Shop Floor Integration, RFID solutions for inventory track and trace
 
Enhanced solutions to address the needs of Lot Genealogy, DEA License Tracking, Contract Management and Chargebacks based on core ERP solutions available in the market
 
Comprehensive range of Compliance Solutions and Services addressing the needs of Audits, Computer System Validation for ERP, LIMS, MES, SCADA solutions available in the market for a regulated environment
 
Business Process Re-engineering Services for achieving a better ROI, reduced time to market, improved quality without compromising on compliance
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