Outsourcing Regulatory Affairs 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.

These 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.

Outsourcing to India, China and other countries with cheap labour 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, Embassy Attestation, increased process speed, reducing time constraints in-house resources, NOC for Import and gaining access to broad global expertise and experience.

Pharma Regulatory Affair sactivities 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, and quality of services delivered, cost benefit, accountability and geographic location/competencies.