Policies

Brogan Pharmaceuticals, Inc is a firm dedicated to the
development and commercialization of pharmaceutical and
biological products for the purpose of treating and diagnosing
disease.  
 

Social Responsibility:

Part of life is work.  We feel all too many firms believe the only way to measure success is through financial accomplishment.  At Brogan Pharmaceuticals a portion of our net income is reinvested for the purpose of identifying and developing future products for rare diseases and the immediate needs of those persons currently afflicted with a rare disease for which we have a product(s) with market authorization in the United States.  We actively engage industry groups, foundations and marketing organizations related to these disease states in an effort to promote awareness, funding research, and collaborative SBIR or STTR grant applications for developing a cure for these rare diseases.  In the spirit of the Orphan Drug Laws we want to make a difference in the lives of all persons.    

cGMP Basic Facts:

The current FDA cGMP's have been developed to assure consumers in the United States that products are both safe and effective for their intended use.  Quality is our number one priority at Brogan Pharmaceuticals.  We build quality into each and every product under development or marketed  commercially.  All products ranging from pre-clinical formulation to Orphan Product distribution are manufactured within our systems to comply or exceed the specifications set forth in:

• 21 CFR Part 11
• 21 CFR Part 209e
• 21 CFR Part 210
• 21 CFR Part 211
• ISO 14644 1 - 7

ISO9001:

IS09001 is an integrated ongoing project and part of the Total Quality Management and CAPA programs at Brogan Pharmaceuticals.  ISO9001 will be validate and achieved prior to the first international delivery of our first product.

HIPPA:

Please contact our offices for our HIPPA agent and agreement.