Regulatory affairs (RA) is a critical function for pharmaceutical and medical device companies in the USA. RA professionals are responsible for ensuring that their products comply with all applicable regulations, which can be complex and ever-changing.
Contract staffing is a popular option for companies that need to supplement their RA teams with experienced professionals on a temporary or project basis. However, there are a number of challenges associated with contract staffing in the USA.
Challenges in USA Regulatory Affairs Contract Staffing
Finding qualified candidates: The RA profession is highly specialized, and experienced professionals can be difficult to find, especially in the USA.
Managing compliance: Companies need to ensure that their contract RA professionals are compliant with all applicable regulations. This can be challenging, as contract RA professionals may be working for multiple companies at the same time.
Building and maintaining relationships: It can be difficult to build and maintain relationships with contract RA professionals, as they may not be with the company for very long.
Cost: Contract RA professionals can be expensive, especially for companies that need to hire them on a long-term basis.
How Artixio Helped US Pharmaceutical Company Register New Drugs on Time and on Budget
A US-based pharmaceutical company that markets and distributes quality, cost-effective generic pharmaceuticals in the United States was planning to register new drugs during Q3 and Q4 of 2023. The company had a small RA team and needed to augment its staff with experienced professionals to meet its regulatory objectives.
The company decided to partner with Artixio, a leading regulatory company. Artixio provided the company with highly experienced regulatory affairs, publishing, and regulatory information management staff. The Artixio team worked closely with the company's RA team to develop and implement a regulatory strategy for the new drugs.
The Artixio team was instrumental in helping the company register its new drugs on time and on budget. The team provided expert guidance on all aspects of the regulatory process, from preparing and submitting regulatory applications to interacting with FDA reviewers. The Artixio team also helped the company to manage its regulatory information effectively and to comply with all applicable regulations.
As a result of the Artixio partnership, the company was able to successfully register its new drugs on time and on budget. The company is now able to bring these new drugs to market and provide patients with access to innovative and affordable generic medications.
Benefits of Artixio's RA Contract Staffing Services
The Artixio case study highlights the many benefits that companies can gain from using RA contract staffing services. These benefits include:
Access to experienced and qualified RA professionals: Artixio has a large network of experienced and qualified RA professionals in the USA. This gives companies access to a wide range of expertise and experience, which can be difficult to find on their own.
Help with regulatory compliance: Artixio's team of experts can help companies ensure that their contract RA professionals are compliant with all applicable regulations. This includes providing training on regulatory requirements and monitoring compliance on an ongoing basis.
Reduced costs: Artixio offers competitive pricing for its RA contract staffing services. This can help companies to reduce the overall cost of bringing new drugs to market.
Increased efficiency: Artixio's team can help companies to streamline their regulatory processes and improve efficiency. This can free up the company's RA team to focus on other priorities.
If you are a company in the USA that is planning to register new drugs, Artixio can help you to overcome the challenges of contract RA staffing and achieve your regulatory objectives.