Outsourcing Regulatory Affairs Services

Outsourcing Regulatory Services: For companies exploring the prospects of the global marketplace, understanding each country’s regulatory requirements can be a difficult and time consuming task. With the changing regulatory scenarios of many developed and less developed nations, companies are finding it difficult to maintain the required in-house regulatory staff to ensure compliance across borders. rnThese significant changes in government regulations, market conditions and technology is forcing pharmaceutical and biotechnology companies of all sizes to embrace new business models that focus on outsourcing of various regulatory activities to reduce the pressure on their in-house team. Drivers for Outsourcing: Many factors contribute to the growth of outsourcing opportunities, with the most obvious and frequently cited being cost savings. Outsourcing to India, China and other countries with cheap labor can commonly help companies realize cost savings of 30-60%. Other considered drivers for outsourcing regulatory activities include: flexibility, risk and security, regulatory impact, timely market approvals, increased process speed, reducing time constraints in-house resources, and gaining access to broad global expertise and experience. Among all the above listed factors, it has been estimated that cost savings is the driving factor for around 80% of companies that decide to outsource regulatory affairs services to an external partner. Companies themselves are finding that by outsourcing routine functions, their in-house resources are able to focus on more strategic and value-added activities, such as regulatory planning for new drug developments and more technical medical writing tasks. Factors to Consider when Outsourcing: Regulatory affairs activities can range from simple tasks to very complex projects involving detailed consultation with relevant regulatory bodies and/or concerned health agencies. Successful outsourcing lies in finding a partner that is able to understand and adapt to an organization’s needs and goals, while performing the functions efficiently and in a timely manner. The following factors play important roles in selecting a partner for outsourcing: experience, flexibility, effective communication, confidentiality, infrastructure, technology, resources, quality of services delivered, cost benefit, accountability and geographic location/competencies. Emerging Models for Outsourcing Regulatory Affairs Activities: Functional outsourcing of regulatory affairs is currently performed by many companies and is a growing industry trend. For small or growing companies it serves as a method to bring extensive regulatory expertise into an organization in a cost effective manner. Since all companies are facing tough times in the current economic climate, various outsourcing models are being utilized for regulatory affair activities. A few common models for outsourcing regulatory affairs services are:

• Staff Augmentation: To expand current capacity to meet short term business needs. This model helps the company by allowing its core resources to concentrate more on new developments and regulatory strategies across the development pipeline.
• Project Based Outsourcing: This is a task oriented activity where outsourcing is limited to specific tasks.
• Full Service Submission Outsourcing: This is suitable for post-marketing activities such as variations, PSURs, annual reports and renewals.
• Functional Submissions: Applicable for pre-marketing submissions for CTA, MAA, NDA, ANDA and different MA procedures such as MRP, DCP and Centralized.
Conclusion With the changing scenario in the pharmaceutical, medical devices and bio pharmaceutical industry, outsourcing in today’s world is no longer limited to basic, mechanical functions. With more stringent regulatory requirements and tighter budgets, companies are eager to outsource more complex activities to external partners. The outsourcing industry is constantly evolving to meet the needs of all life sciences organizations and ultimately allow internal resources to concentrate on their core competencies all while drastically reducing overall cost.