Pharmaceutical Regulatory Compliance
Industry Challenges
The legal landscape for pharmaceutical industry is changing continuously. To successfully traverse that landscape requires strong intellectual property and a pathway through the regulatory terrain, challenges faced in the life of every new drug. Companies and Universities now often combine efforts, resources, and roles to bring a drug to market.
Currently the main areas under regulatory compliance for Life Sciences industries are:
- Lack of expertise in obtaining regulatory approvals
- Process improvement and effective utilization of resources to sustain market competitiveness
- Rapid filing of the DMF's (Drug Master Files)
- Intellectual Property Rights (IPR) Management
- Implementing GxP systems by effective change management
- Customer Relationship Management (CRM)
- Rapid data recovery
- Compliance to international regulatory norms
- Integrating diverse data transacted across the business process
HCL Differentiators
- One stop shop for Consultancy Services, Solution Implementations, Submissions, Audits and Process Definitions
- First offshore vendor to be certified for ISO: 13485
- The vertical has a deep understanding of the business domain and there are many professionals who are certified to the specific industry certifications like HL7, HIPAA and SOX etc
- The professionals, with an average of 7-10 years of industry experience, provide functional solutions, with the assistance from the core technological superiority of HCL Technologies in supporting these solution frameworks
- Complete awareness about upcoming as well as current regulations like 21-CFR-Part 11,210 & 211 and GxP
- Clear understanding of Documentum product roadmap because of Product Engineering relationship with Documentum
- Consultants who are members of RAPS (Regulatory Affairs Professional Society)
- Faster and easier compliance through a robust, tool-based approach
- Higher quality compliance
- Cost effectiveness
- Opportunities to improve/enhance systems and processes
- Ability to leverage compliance needs for re-engineering and e-business initiatives
Service Offerings
HCL’s Regulatory Excellence Services spans across all the Life Sciences industries (Medical devices, Pharmaceutical & Biotech Industries and Healthcare). HCL address the entire value chain of Pharmaceuticals companies starting from the Research & Development to commercialization of the drug / device across the entire supply chain.
HCL solutions cover the full suite of regulatory and compliance requirements. It provides its clients:
- Well Structured Methodology for ensuring Compliance
- Compliance Gap Analysis
- Remediation of Applications for Regulatory Compliance
- Code sets and Identifiers
- EDI Transactions
- Privacy and Security Requirements Implementation
- Compliance Testing
