Marketing Authorisation Holder (MAH) refers to a person or company that has been granted permission to market a pharmaceutical product within a specific country. MAHs are subject to a number of regulatory requirements and ensure pharmaceutical products meet stringent safety and quality standards. As regulatory frameworks are becoming more stringent, many companies are turning to third-party experts as a solution to meeting these challenges. Pharmaceutical MAH outsourcing is one prominent example, allowing organizations to delegate compliance and regulatory monitoring tasks to specialized service providers. By tapping external expertise, companies can navigate through diverse regulatory environments more efficiently while maintaining competitive advantage. Additionally, many companies are looking for outsourcing options to maximize operational efficiency and reduce the overhead that comes with handling intricate regulatory frameworks internally.
Rationale for Outsourcing MAH Responsibilities
Pharmaceutical outsourcing of MAH responsibilities has become an effective strategy in recent years for many reasons. Companies often focus on their core competencies while delegating functions requiring specialization to Contract Research Organizations (CROs).
- Focus on Core Competencies: Outsourcing can allow companies to focus on their core strengths such as research and innovation while assigning non-core functions to external partners.
- Cost Reduction: Outsourcing can enable companies to reduce capital asset investments and operational costs, thereby enhancing overall financial efficiency.
- Access to Expertise: Outsourcing allows access to therapeutic expertise as well as knowledge of local regulatory requirements, which is particularly useful when entering new markets.
- Risk Management: Partnership with outsourcing partners can help in sharing both management and financial burdens, reducing operational risks in drug development and supply chain logistics.
How Outsourcing MAH Impacts Global Expansion Strategy
When expanding globally, a strong regulatory strategy is just as important as an effective global marketing strategy for pharmaceutical success. Regulatory efficiency directly impacts a company’s ability to position its product in a competitive market, as delays in approval can hinder market entry, disrupt launch timelines, and affect brand credibility. By ensuring a seamless regulatory process, companies can better align their marketing and commercialization efforts with product availability, ultimately strengthening their global presence.
Streamlining Global Market Entry: As third-party MAH services are well-versed with the local regulatory requirements; outsourcing MAH saves both time and cost for pharmaceutical companies. Further, this also expedites the product approval process and reduces delays or rejections
Optimizing Resource Allocation: Strategic outsourcing enables pharmaceutical companies to focus on their core competencies like research and development, and product innovation instead of establishing and maintaining costly regulatory and compliance teams for each market. MAH outsourcing also leads to substantial cost savings while optimizing resource allocation.
Enhancing Regulatory Compliance and Risk Management: Maintaining compliance and managing different international markets simultaneously is a difficult and demanding task. An association with a reliable outsourcing partner provides ongoing monitoring of regulatory evolution and proactive response to new regulations. This reduces the risk of non-compliance that can result in delays in product approval or recalls. Effective risk management is essential to protect the company’s interests and ensure the longevity of its expansion into the global market.
Overcoming Market-Specific Barriers: Each market has its own set of challenges, such as distribution complexities, regulatory requirements, and pricing pressures. By utilizing seasoned local players who are familiar with local regulations, pharmaceutical outsourcing enables businesses to overcome these challenges.
Case in Point
Consider a mid-sized pharmaceutical company planning to enter the European and Asian markets. By partnering with an experienced outsourcing provider:
- In Europe:
The partner’s established relationship with EMA officials and understanding of EU regulatory frameworks helped the company secure faster approvals.
- In Asia:
Local regulatory nuances and language barriers were navigated effectively, minimizing delays and ensuring compliance.
However, the company also implemented robust internal controls and regular audits to maintain oversight, addressing potential concerns about losing direct control.
Conclusion
Outsourcing MAH responsibility allows pharmaceutical companies to better comply with regulatory requirements, streamline operations, and enhance global marketing strategies for their products. While cost-saving remains a benefit, the strategic advantages in compliance, risk management, and market access outweigh pure financial motives.
Pharma companies are now focusing on their core areas like R&D and outsourcing services which demand extra teams and resources. As competition increases in the global pharmaceutical market, outsourcing can be an invaluable strategy for businesses seeking effective and sustainable growth.
Partner with DDReg today and take the next step towards a seamless global expansion strategy.
In addition to providing regulatory and pharmacovigilance services for global customers, DDReg Pharma offers specialized clinical regulatory services to assist with Clinical Trial Applications in the United States. For further information, connect with our experts. Read more about REMS regulations from the experts here: Tackling Global Market Access Barriers in Pharma Regulation