Goldwin & Associates, offers full product development services to generic pharma companies and specialty pharma focused on the development of new improved versions (value-added generics or generic plus) of established drug products. Typically, our clients approach us with a specific development request but occasionally, we are also asked to investigate and propose new product opportunities based on the existing drug portfolio of our clients. Although in general the overall aim of value-added generic development projects is focused on improving the safety, efficacy and/or the ease of administration, we are also specialized in executing development programs where the primary or sole objective is the evasion of existing product patents.
Over the past 10 years, Goldwin & Associates, has expanded its spectrum by establishing state-of-the-art LaboratorieOver the past 10 years, Goldwin & Associates, has expanded its spectrum by establishing state-of-the-art Global Laboratories facilities and provides research & development services. Also a nexus of services such as :
- Pre – formulation
- Formulation
- Lab Scale Trials
- Compatibility Studies
- Scale – up Feasibility Studies
- Stability Studies
- Critical Quality Attributes
- In Process Controls (IPCs)
- Design Space (QbD)
- Production Validation
- Production Transferability
- Production Scale – up
- Analytical Development
- Analytical Validation
- Multimedia Dissolution Studies
- Methods: HPLC, GC, Dissolution Testing USP 1 & 2
- Flow Studies
- Solubility Studies
- Clinical expert reports
- Toxicological expert reports
- Bioequivalence studies
- Comparative clinical studies
- Clinical efficacy studies
- Documentation preparation
- Regulatory Strategy
- Regulatory services (CTD preparation etc)
- Regulatory submission & approval