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Chemistry, Manufacturing & Controls
The Weinberg Group assists clients in the strategy, preparation and submission of chemistry, manufacturing and controls regulatory information to worldwide authorities for IND’s, NDS’s, CTD’s, PLA’s, 510(k)’s, PMA’s, Combination Products, Amendments, Supplements, Annual Reports, and CBE’s.
Related capabilities include:
- Pharmaceutical Development for Technical Issues – Expeditious product development activities to obtain marketing approvals depend on the careful planning and execution of steps individually and in tandem, guided by Project Management tools, Critical Path assessments, and Decision Points evaluation processes to optimize time, money and resource constraints.
- Analytical R&D Issues – Development of scientifically valid and defendable technical data in support of Regulatory Filings and operational document transfer support through the lifecycle of the product.
- Technical Regulatory Strategy and Evaluation Services – Critical, objective, experienced, third-party evaluations of internally derived technical data, leading to the creation of GAP Analyses, recommendations, and options for addressing the Gaps, keeping in mind that there are Risk/Benefit assessments associated with each proposed course of action that can impact the business.
- R&D Audits for Development Projects – Data Integrity Certification Services
- SOP development and review for GXP activities
- Bioanalytical data reviews in support of pre-clinical and clinical data results
- Assessment of raw technical data as the basis of Final Reports
- Service as the Regulatory and/or QA Agents on behalf of clients who desire or require this arrangement
- Laboratory Practices and Compliance Issues
- GLP: Analytical Issues, Audits, and Data Management
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