Regulatory Strategy & Due Diligence
Every pharmaceutical company requires a proactive regulatory strategy to ensure compliance with the regulations governing the development, approval, and marketing of drugs and medical devices.
At Techsol, our Regulatory Affairs professionals specialize in completing due diligence which involves a comprehensive evaluation of a pharmaceutical or medical device company’s compliance with relevant regulations and standards, prior to a merger, acquisition, or investment. This process typically involves reviewing the target company’s regulatory submissions, marketing and labeling materials, quality systems, and manufacturing facilities to identify any potential liabilities or risks associated with the target company’s regulatory compliance status.
With over 15+ years experience, our Regulatory Affairs team has helped several pharma and medical device companies to meet regulatory obligations in a timely manner by:
- Helping Client Teams understand latest Regulatory Requirements
- Developing a comprehensive Regulatory Compliance Roadmap
- Preparing and submitting applications to Global Regulatory Bodies
- Managing all Regulatory Related Interactions with Health Authorities
- Leveraging latest technology for Regulatory Information Management
- Monitoring Regulatory Developments and implementing Changes
Service We Offer
Our Regulatory Strategy services involve advising and assisting pharma and medical device companies to navigate the complex and constantly evolving regulatory landscape to ensure compliance with relevant laws and regulations. Our due diligence services involve conducting a comprehensive review of a target company or asset to assess its potential risks, liabilities, and compliance with applicable laws and regulations. We help clients identify and manage regulatory risks, developing and implementing compliance programs, and representing clients in regulatory enforcement actions and investigations.
To have a practical regulatory strategy, it is important to evaluate your marketed and pipeline product portfolio and target geographical regulatory requirements. Our team can conduct a preparatory compliance audit by performing thorough analysis of relevant laws, regulations, and guidelines that are applicable to each of your products to:
> Identify non-compliance risks as per the latest regulations
> Prepare long-term regulatory roadmap for each product
Based on the outcomes of the preparatory compliance audit, our experts can help in creating repeatable quality processes for:
- Submission Forecast and Planning
- Submission Document Management and Tracking
- Regulatory Content Management
- Change Control Management
- Label Changes Tracking
