Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis

 

Outsourcing has become an increasingly common practice in the Pharma and Biotech industry more so in the area of regulatory affairs and Pharmacovigilance. Regulatory outsourcing has now become a norm as most companies are seeking partners to manage operational tasks including report publishing and submission publishing.

The healthcare regulatory affairs outsourcing market is experiencing significant growth owing to services to Clinical Research Organizations. The rising number of patent expirations along with growing costs of research and development activities are the primary factors influencing the growth of the global healthcare regulatory affairs outsourcing market. Healthcare and biopharmaceutical organizations are likely to team up with numerous outsourcing companies for getting their drugs and devices approved in the global market. The approval time of a drug or device is a time taking process, is expensive, and is also a documentation centric procedure.

These type of regulatory service providers provide several other services as well such as pharmacovigilance, medical writing, and clinical trials to biotech and many different countries. However, the market is expected to be inhibited by the high fluctuations in price along with hidden expenses in the regulatory services delivered by diverse Clinical Research Organizations. Furthermore, high risks pertaining to organizational information security is likely to challenge the productivity of the healthcare regulatory affairs outsourcing market.

Regulatory policies are implemented to ensure that companies comply with certain standards of functioning in relation to their businesses. These policies or regulatory affairs in the healthcare industry are aimed at safeguarding the public health and welfare by ensuring the safety of pharmaceutical and healthcare products. An increasing number of healthcare companies lately are outsourcing their regulatory functions to focus on their core competencies instead. Furthermore, due to the advent of an increasing number of drugs in the clinical development process, regulatory affair outsourcing is gaining more importance in the healthcare sector.