Services

1. Regulatory Services 7/12/2010

   For all commercially manufactured products PharmaZell holds Drug Master Files (DMFs) and/or Certificates of Conformity with the European Pharmacopeia (CEPs) with health authorities in the US, Europe, Japan, Canada and Australia for all active pharmaceutical ingredients.

2. Analytical Services 6/1/2012

   Cedarburg Hauser Pharmaceuticals’ on-site analytical lab and chemists make sure all processes are qualified, validated and replicated at each stage of your API’s development.

3. Regulatory Services 6/1/2012

   If you need help preparing and submitting your API regulatory applications, Cedarburg Hauser Pharmaceuticals has the knowledge and experience it takes to efficiently guide you through the complexities of the FDA submission process.

4. Regulatory Consulting and Review 6/26/2006
   Drug Development Services- Camargo’s expertise in regulatory affairs and submissions runs the drug development gamut: pre-IND and IND preparation and submissions; pre- and post-IND and NDA meetings with the FDA; and the preparation and submission of NDAs, ANDAs, and 505(b)(2) NDAs
5. CMC Strategy and Management (Chemistry, Manufacturing and Control) 6/26/2006

   Camargo’s early involvement in the drug development process saves our clients substantial time and money. From API and formulation sourcing to manufacturing, scale-up and packaging, we provide Camargo clients with invaluable strategic guidance and management services.