Dr. Raymond E. Dagger
Stonehedge Pharmaceutical Consulting, LLC
13121 Old Annapolis Rd.
Mount Airy, MD 21771
Phone:
(301) 602-4605
E-mail: redagger@comcast.net
Specialties:
- Organic Chemistry
- Synthesis
- Product Development
- Chemical Process and Drug Product Development
- cGMP
Services:
Stonehedge Pharmaceutical Consulting brings strategy, discipline, speed, accuracy, regulatory compliance and fiscal control to the drug development process.
Stonehedge is led by a pharmaceutical executive with over 30 years experience with large, medium and emerging pharmaceutical companies, experience working in North America, Europe and Asia, a proven track record of success and an extensive network of development professionals and service providers.
Stonehedge is focused on small molecule drug development with and emphasis on Chemistry, Manufacturing and Controls.
We offer:
- CMC Project Management
- cGMP SOP Development
- Active Pharmaceutical Ingredient Chemical Process Development
- Analytical Methods Evaluation, Development and Validation
- Contractor Selection and Evaluation Using a Matrix Process
- Contractor Management
- Management of cGMP Processing
- Dosage Form Selection
- Formulation Development
- Preparation of CMC Section of INDs, Annual Updates and NDAs in both Paper and Electronic Format
- CMC Due Diligence
- Independent Third Party Structural and CMC Package Review
- Packaging, Labeling and Clinical Supply Management
- Cost of Goods Supplied Modeling
