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Regulatory Systems
Cedarburg can efficiently guide you through the ins and outs of the FDA submission process. We have successfully filed multiple DMFs in North America and Europe. Through partnerships with our customer, we have assisted with writing CMC sections of ANDAs and NDAs. In addition, Cedarburg has a strong relationship with the DEA. We have permits and quotas for Schedule I through Schedule V controlled substances.
With our strong history of regulatory compliance and our positive relationships with the FDA and DEA, Cedarburg will smoothly navigate your product to the market or prepare it for licensing.
All cGMP compliance activities at Cedarburg are under the direction of Ms. Hughes.
Areas included are:
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Documentation |
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Personnel |
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Facilities and Safety |
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Production and process controls |
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Reviews and inspections |
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Packaging and labeling |
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Quality control and analytical controls |
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Equipment |
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FDA registration and inspection |
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> Download a Cedarburg Brochure |
