Services
-
Trace Analysis & Structural Chemistry
1/28/2010
ABC Laboratories delivers expert CMC analytical support and Quality Control for API and drug product across most dosage forms.
-
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.
-
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.
-
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.
-
Biotech Development Services
2/2/2010
Analytical Bio-Chemistry Laboratories Biotech Development Services.
-
Drug Development Consulting
1/29/2010
How do I move my compound to the next milestone? What types of studies will regulators require? The answers to these questions depend on your compound, its intended purpose, mode of delivery and many other variables.
-
Bioanalytical Testing: Preclinical - Phase III Clinical Trials
1/28/2010
ABC Laboratories offers dose formulation and routine bioanalytical testing for preclinical through Phase III clinical trials.
-
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
-
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.