Pharmaceutical Drug Law

Pharmaceutical Drug Law relates to the creation, manufacturing, sale, and distribution of pharmaceutical drugs.

Intellectual Property
Patents are very important in pharmaceuticals because they often encompass the bulk of the drug asset.  Without patents, the innovator is often displaced by lower margin generics.  The smallest companies in the pharmaceutical and biotech space often leverage their patents to raise the capital investment necessary to reach marketing approval.  Trademarks, trade secrets, and copyrights are also extremely important in this area of law.

Quality and Marketing
No industry holds itself to a higher standard of quality than the pharmaceutical industry.  For this reason, FDA quality requirements are extremely important to gain marketing authorization in order to sell product.  Once the product is on the market, quality is still an ongoing obligation.  Our attorney has personally worked within the quality systems of a pharmaceutical and understands the unique needs of the industry.

Establishment Registration

Paragraph IV Certifications

Orange Book Issues

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