PROBLEM: Your staff is delayed in preparing documents and/or submissions required to obtain clearance or approval from governmental agencies for global commercial distribution of products.
IMPACT: Unfortunately, a slippage in timeline of even a few months can have a substantial negative impact on your bottom line. For instance, you might experience:
- The standby costs of capital equipment (plant and machinery) unable to manufacture product. Idle equipment is a drain on your bottom line.
- The standby costs of personnel who were to be involved in product manufacture, distribution, sales and administration. Will you lay them off and need to staff up again? Even if you decide not to lay off personnel, the personnel you will have available when you eventually do get approval is not the same personnel you had before. Not being able to work to potential will have a negative effect on employee morale. Your best employees may leave for greener pastures.
- The opportunity cost as others beat you to the market. While you are unable to sell product, your competitors are eating your lunch. Instead of being an industry leader, your product will become a “me too” option that will never catch up.
- The opportunity cost of missing the agencies’ window for review and decisions. Not being ready when they are scheduled to review may put your launch off by a year or more.
- The requirement to re-work all of your launch brochures and other collateral. Communications materials that have been developed and then put on hold before going to press will inevitably have to be re-written and re-worked. Launch materials developed for your first-to-market offering will not be appropriate for a “me to” product.
SOLUTION: What if you had a pool of pre-qualified and experienced US and OUS regulatory professionals that you could draw on at a moment’s notice? What if you used these additional resources to get caught up and back on track, allowing you to get your product through the review cycle in a timely way and to market on schedule? By using a flexible professional staffing solution, Talencio recently helped a Minneapolis-based medical device company significantly shorten product review cycles and time to market within the EU and Australia.
Talencio has partnered with numerous medical device companies throughout the U.S., supplying experienced life science professionals ranging from Regulatory Specialists to VP Regulatory-level talent. Our professional talent has assisted in successful U.S. and global submissions for a variety of products, from cardiology to sleep apnea to urology-related therapies and more.
Problem not with regulatory submission staff? Our talent includes experienced engineers, laboratory scientists, clinical research experts, quality professionals, and many others.
Let us partner with you to avoid delays, fill personnel gaps, provide specialized expertise on a short-term basis and help you move forward. Use of temporary life sciences professionals to support your team is an effective strategy to avoid employee burnout, keep projects running smoothly, increase workplace morale and ultimately, increase your revenues and profitability.
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To learn more about how Talencio has helped other life science companies, just like yours, solve this and other staffing issues, contact us directly at 612.703.4236 or firstname.lastname@example.org.