Pharmaceutical companies are innovative and generic drugs marketed in countries around the world. With limited market potential and varying products portfolio in Asian countries, companies often face unique and complex challenges. These challenges can impact the speed at which products are brought to market, maintain the compliance for marketed products, ensuring supply chain and business continuity, the quality of those products, and the company’s overall profitability. Here are nine key challenges that pharma companies often encounter that can be addressed using Regulatory Contract Staffing:
1. Limited Portfolio of Products
Companies with a limited portfolio in each country often find it financially unviable to hire full-time regulatory experts. This can lead to a lack of in-house expertise and potentially slower product approvals.
2. Requirement for Qualified Regulatory Professionals
Finding qualified professionals who are well-versed in the intricate details of regulatory affairs is a common challenge. The demand for such professionals often outstrips supply, leading to a talent crunch in this critical area.
3. Proficiency in Regional Language and English
Regulatory personnel must be bilingual or multilingual to effectively communicate with global teams and understand regional regulations. This language barrier can often slow down regulatory processes and lead to misunderstandings.
4. Relationship and Prior Experience with Local Health Authorities
Having established relationships with local health authorities can aid in smoother navigation through the approval processes. However, this is often a hurdle for new entrants who lack these connections.
5. Understanding of Complex Regional Regulations
Each country has its own set of regulations which can be complex and varied. Managing these effectively requires specific expertise and a deep understanding of the local regulatory landscape.
6. Navigating Import and Custom Regulations
Complex importation and custom regulations can delay product launches and impact market penetration strategies. Companies must be well-versed in these regulations to avoid costly delays and potential legal issues.
7. Product/Therapeutic Area Experience
Having personnel with specific product or therapeutic area experience ensures that regulatory requirements are met efficiently. This specialized knowledge can expedite product approvals and ensure compliance with all relevant regulations.
8. Flexibility to Scale Team Size
The ability to scale up or down the team size as per the changing workload or size of the product portfolio in the country is a significant challenge. Regulatory affairs is a dynamic field, and the workload can vary greatly depending on the product pipeline and regulatory changes. Companies need to have the flexibility to adjust their team size quickly and efficiently to meet these changing demands.
9. Data and Information Security
With the increasing digitization of regulatory processes, data and information security has become a paramount concern. When working with regional teams, ensuring the confidentiality and integrity of sensitive data is crucial. Any breach can have serious implications, including regulatory penalties and loss of trust among stakeholders.
These challenges underscore the need for strategic planning, investment in training and development of personnel, and fostering relationships with local health authorities. Overcoming these hurdles requires partnering with experienced and reliable companies with local presence, and leveraging technology to streamline processes ensuring that products meet the stringent regulatory requirements while being launched timely into the markets.
Regulatory Contract Staffing from Artixio for Pharmaceutical products Lifecycle Management
Artixio offers contract staffing solutions to address these key challenges in Asian countries such as India, Singapore, Malaysia, Indonesia, Philippines, Vietnam, Thailand, Hong Kong, Taiwan, China, Japan, and South Korea. Artixio has experienced regulatory professionals based in these countries who have worked in the industry for over 15 years, helping complex pharmaceutical and biologic products get approval and maintain compliance with regional health authorities. This approach allows companies to overcome these challenges and ensure the smooth and efficient management of their products’ regulatory affairs.