Global regulations are constantly shifting and changing in the pharmaceutical and medical device industries. It can be challenging to stay up to date when you’re already in production and so many things are going on at your company. But the stakes are high – if your product is not in compliance, it can lead to delays, recalls, or even legal action. Hiring a consulting firm as a strategic partner can help you nimbly navigate regulatory compliance challenges and save time and money in doing so.
Consulting firms bring decades of compliance experience to the table regarding FDA, EMA and other global regulatory bodies. EMMA International has former FDA consultants and industry subject matter experts that have a wealth of knowledge to help clients. Our specialized knowledge and expertise ensure that clients get up-to-date information on the newest regulatory standards. Further, EMMA International has the experience and skills, and core competencies to draft creative and practical solutions to unique complex compliance issues.
Anyone can look up FDA regulations [1], but it is incredibly time-consuming to find the appropriate regulation, and then correctly interpret it. EMMA International is already well-versed in this, which saves our clients time, so they don’t have to muddle through on their own. If an inexperienced person attempts to interpret a regulation on their own without an expert guiding them, they can risk fines or delays if they make an incorrect assumption. Sometimes outsourcing compliance or relying on a consulting firm for weekly regulatory guidance assistance can be the fastest, most accurate, and cost-effective solution for your company.
Investing in a consulting firm for compliance assistance can offer a strategic advantage to help get your product to market sooner. Partner with EMMA International today.
EMMA International is here to provide full-circle solutions for all aspects of the pharmaceutical and medical device industries. 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 (2023) FDA Related Laws, Regulations, and Guidances, Retrieved on 19 November 2024 from: https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/fda-related-laws-regulations-and-guidancesmers-cures
