Services

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Our team has launched over 1000 OTC drug products from dandruff shampoos to toenail fugus treatments and everything in between.  We are experts in making sure your labels and documentation meet the requirements of the monograph getting your NDC code into the system and your product into the market.

The FDA is not the enemy but a free partner in helping protect the consumer by making your products better.  With the right framework and business plan every 483 observation can be corrected, implemented and eliminated from future observations.

Contract manufacturing and filling is a challenging and competitive world.  Our team can help streamline your processes to increase profits or we can search out and find the right company to get your product to the market. Ways of processing can be improved, line speeds can be increased while reducing rejects.  Let us find low cost solutions to your problems.

Our team can help guide you in creating a stability program for your product that meets regulatory compliance while not breaking your bank.  Stability programs take time but with careful thinking a scientific approach with all risks taken into consideration will expedite the process.

Inventory control, raw material approval, just in time manufacturing are all part of the daily work routine but shortfalls impact bottom lines. There are simple solutions to help speed things along.  A extra pair of eyes is all that's needed with a on-site inspection of processes and layouts.

Now is not the time to panic.  The FDA welcomes companies to reach out to reliable consulting firms to help with getting your business back on track.  Warning letters are critical and you need to act quickly.  We can help you move on to the next level of compliance.