The regulatory landscape in biotechnology is constantly changing and evolving – and in turn, new companies must be anticipating these shifts. Proactive steps for regulatory compliance are essential, particularly for start-up companies that are competing with larger, established companies in the market. It is never worth it to skimp on quality or regulatory strategy to move faster. While compliance may seem daunting, emerging biotech companies can easily navigate the intricacies of compliance with the help of EMMA International.
Challenge 1: Understanding Regulatory Pathways for New Biotech Products
It can be difficult to identify the correct regulatory submission for your innovative product (e.g., 510(k), PMA, De Novo, HDE [1], INAD, NADA, ANDA [2], etc). It’s beneficial to plan with experienced regulatory advisors to determine the best path forward. Start-ups may lack the resources to effectively navigate complex FDA standards and guidance documents. In these cases, it is best to hire an experienced consulting firm.
Challenge 2: Ensuring Compliance with Evolving FDA and International Regulations
Even after receiving authorization from the FDA or other global regulatory authorities, companies must monitor their device performance, track complaints, open CAPAs as necessary, and allow for routine inspections [3]. Further, these regulations change over time, and it can be difficult to keep up. These changes can impact production and market strategy. To address this, companies should implement ongoing regulatory monitoring and quality/regulatory training for employees. EMMA International can help companies adjust to regulatory changes and train employees.
Challenge 3: Managing Quality Assurance in Product Development
High quality products are the foundation of good business practices. Maintaining high-quality standards through Good Manufacturing Practices (GMP) can be challenging for a small start-up. A robust QMS can make a huge difference in maintaining GMP and quality standards. It can be helpful to outsource QA initially or hire a consulting firm to develop a custom QMS for your product and train employees to manage quality.
Sometimes the fastest and most cost-effective solution is to partner with an experienced consulting firm to address these challenges.
EMMA International can help choose the correct regulatory pathway, help with your submission, ensure compliance, create your QMS, quality and regulatory training, and manage changing regulations for biotech. Give us a call at 248-987-4497 or email us at info@emmainternational.com to learn more about how EMMA International can take the stress out of quality and regulatory compliance!
[1] FDA (2018) Step 3: Pathway to Approval, Retrieved on 1 November 2024 from: https://www.fda.gov/patients/device-development-process/step-3-pathway-approval
[2] FDA (2020) From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process, Retrieved on 1 November 2024 from: https://www.fda.gov/animal-veterinary/animal-health-literacy/idea-marketplace-journey-animal-drug-through-approval-process#beginning
[3] FDA (2018) Step 5: FDA Post-Market Device Safety Monitoring, Retrieved on 1 November 2024 from: https://www.fda.gov/patients/device-development-process/step-5-fda-post-market-device-safety-monitoring
