Pharma companies need to be well-versed regarding regulatory intelligence while develop, manufacture and release products into the market.

Companies have to analyze, monitor and gather the information which is available in the market, to understand, develop and make decisions while manufacturing
Regulatory intelligence will be more helpful to the pharma companies for the preparation, planning and development.

Any deviation in the process can also be identified, rectified while the pharma company knows the complete information of regulation in that pertaining country.

To track & maintain the complete information of the regulatory intelligence in the global pharmaceutical sector, every pharma company will get many challenges during the process. Some of the challenges and opportunities are briefly described below.

Challenges:

“DATA“ is the most important challenge for every pharma manufacturing company and struggle more.

• Regulatory intelligence changes rapidly and regulatory authorities will release that country regulatory updates on ‘time to time’, Companies need to be well-informed on these updates
• Data with respect to collection, storage, updates and maintenance including regulatory grade security
• Real time gathering the data which includes all the information that give updates by the regulatory agencies may also include Guidelines, Rules, Directives, Countries Laws, previous approvals and their regulations, Alerts, News, sometimes meetings and conferences
• Continuous checking for updates and gathering the data will not be possible without the research professionals
• Analyzing and taking the strategic decisions will not be that easy without the certified professionals or experts
• Some of the countries regulatory data will be publically available and can get the data from the regulatory authority websites, but there are countries with very less data and follows old regulations which cannot give continuous updates, for these kind of countries very vast research required
• Once the data collected, pharma companies need analysis to make decisions
• To keep the employees on the same track and make awareness about that specific country regulations , companies have to release updates alerts or news and also need to keep & maintain in ‘TOOL’
• Inadequate regulatory information can also increases the budgets, takes more time to launch the product into the market and deviations or regulatory issues from the specific country regulatory authorities
• Specific product regulatory information can also be a major challenge but can be achievable by following regulatory processes from the country specific authority
• For International exports & imports, manufacturers need to get all the regulatory data
• Segregation of the regulatory data also a big process
• Gathered data need to be processed and evaluated to achieve regulatory compliance
• Need to achieve global regulatory harmonization due to many companies involve in different stages of the product development
• Ethical concerns have to be monitored at each and every step of the process
   

Opportunities:

Regulatory intelligence gives many opportunities to the pharma companies that are discussed below:

• Increased regulatory transparency
• Cost effectiveness
• Timely and consistent submissions across global markets
• Time bound approvals from the regulatory authorities, no need to wait while the pharma companies already know the timelines i.e. Effective approval process
• Regulatory compliance can be achievable
• Global harmonization can be achieved by follows the regulatory updates
• Regulatory intelligence creates more dynamic employment for the researchers and experts
• Can easily track the constantly changing regulatory changes
• Uniform maintenance of data, forms and versions of documents
• Maintains quality standards of data across the globe which impacts on brand quality, image
• Proactive in taking decisions and policies
• Effective communication between the companies and regulatory agencies can be achieved
• Volatile, complex and unsolved problems can be minimized
• A regulatory professional increases their skills and knowledge which impacts more in their carrier development
• Advances in the development of the products can be known and can be tracked
• Innovation of the new products and improved decisions in the process can be achieved by understanding the global regulatory, market trends which will be possible by using regulatory intelligence

Use of Regulatory Intelligence Tool:

• Technology aided pharma regulatory intelligence tools will gives the best with respect to data driven, security and long life access to the regulatory data
• In the new Digital era, Regulatory Intelligence tool could be a cloud based platform which can access anywhere, anytime in the world
• Tool which protects from the Hackers and malware and gives the enterprise grade regulatory security
• All the confined data with specific frame work will be given in the tool
• Pharma companies can focus on the their development and by use of regulatory intelligence tool , over budgeting can be minimized
• Real time knowledge supports can be availed
• Tool will gives the segregated data and give out the simple step process and also download the required documents in simple clicks
• Accelerated process training for the employees can be done easily
• Regulatory intelligence tool can save lot of time and expenses
• Regulatory intelligence tool is a proven solution for the pharma markets to become successful

Stay ahead in the Pharma Industry with our Regulatory Intelligence Solutions. Explore Now and ensure compliance for successful drug development.