With dynamic requirements in the Pharmaceutical and Life sciences industry, especially with respect to regulatory compliances, staying competitive poses a serious challenge in today’s corporate scenario.  To successfully overcome this landscape requires strong intellectual property and a pathway through the regulatory terrain. Any feasible solution must include a sophisticated enterprise-class IT enabled clinical software platform that minimizes product development costs and guarantees value-addition in order to reduce the time for successful electronic submissions.  Moreover, the maturing of clinical data standards like those of CDISC is setting the stage for proactive data management in trials – a strategy that is gaining significance.

Organizations are bogged with several challenges in meeting regulatory compliances on time and some of the pain areas in this context include:

• Lack of expertise in obtaining regulatory approvals
• Process improvement and effective utilization of resources to sustain market competitiveness
• Rapid data recovery
• Compliance to international regulatory norms
• Integrating diverse data transacted across the business processes

In the light of the above discussion, MST’s Regulatory and Compliance Management services are aimed to address the above issues, wherein we offer a well-structured methodology to take care of the entire process starting from Data Definition strategy planning to standard data submission. We incorporate advanced methodology and technological expertise to generate the Electronic Common Technical Document (eCTD), validate data to ensure compliances with CDISC and HL7 standards and finally ensure effective submission of data, meeting all regulatory requirements. All this translates to lower costs, high degree of data security & integrity, greater regulatory compliances and above all enhanced operational efficiency.

Our Expertise

The key to the success of our Regulatory and Compliance Management Services is our extensive knowledge of the pharmaceutical industry and regulatory requirements, including exposure in identifying and delivering effective and regulatory-compliant solutions. Our broad experience includes identification of key parameters from a compliance perspective, performance of regulatory consulting services for esteemed clients that include pharmaceutical, life sciences & health care organizations, Contract Research Organizations (CROs), software vendors and Application Service Providers (ASPs).

Key service Offerings:

• Integrated and Automated processes to reduce manual interventions, thus speeding up deliverables.
• Easy generation of profiles in both proprietary and CDISC standard data formats
• Support for multiple studies and geographically distributed user bases under single platform
• Generation of tables, listings & graphs by both SDTM and ADaM data models
• Web-based and collaborative environment for simple to complex statistical analysis
• Role-based security | version control | change impact | audit trail | traceability | Data blind management
• Compliance with standard guidelines and best practices – GCP-ICH, CDISC
• User friendly Data mapping and Metadata creational wizards
• Default Provision of industry related standard metadata
• Configuration of Workflow driven transformation plan
• Integrated validation component for validating regulatory compliances
• Consumption of Source data from different sources using integration adapters
• Import and Export of metadata from and to different sources
• Implementation of Privacy and Security Requirements
• Compliance Testing

How do you benefit?

• Faster and easier compliance through a robust and tool-based methodology
• Higher quality compliances
• Non-labor intensive and very user friendly
• Cost effective service at a reduced TCO – Pay per need
• Round the clock support
• Scalability to support multiple studies in parallel
• Opportunities to enhance existing systems and processes