At BACHwell, we offer a comprehensive suite of consulting services that cover every aspect of pharmaceutical development. Developing stable and effective drug formulations can be a challenging and resource-intensive task. Our Formulation Development Consulting Services help you overcome these challenges by providing customized solutions for optimal drug delivery and efficacy. We ensure that your formulation development process is aligned with your product’s therapeutic goals, enhancing both bioavailability and patient compliance.
Key Offerings
- Formulation Option Exploration
- Drug Delivery Optimization
- Innovative Formulation Techniques (Nanoformulations, Liposomal Formulations)
Process Development Consulting
Transitioning from lab-scale to commercial-scale production requires expertise in process development. Our Process Development Consulting focuses on designing scalable, efficient, and cost‑effective processes that ensure consistent product quality.
- Scalable Process Design
- Process Optimization
- Technology Integration
- Troubleshooting and Consistency
Our Core Services
Product Development Services
- Literature Search – Comprehensive research and analysis
- Intellectual Property (IP) Review – Ensuring patent compliance
- Pre‑Formulation Development – API characterization & excipient selection
- Compatibility Studies – API‑excipient interaction analysis
- Formulation Development & Optimization – Stable and effective formulations
- Packaging Development – Primary & secondary packaging selection
- Process Development & Optimization – Efficient manufacturing
- Scale‑Up & Technology Transfer – Lab to production
- Process Validation Studies – Robustness & regulatory compliance
Analytical Development Services
- Analytical Method Development & Validation
- Cleaning Method Development & Validation
- Stability Studies (ICH Guidelines) – Shelf‑life & degradation analysis
- Method Transfer – Smooth transition of validated methods
Intellectual Property Rights (IPR) Support
- IP Landscape Preparation – Patent strategy development
- Support for Formulation Development IP – Regulatory & patent considerations
- Infringement & Non‑Infringement Analysis – Risk mitigation & compliance
- ANDA Certifications – Regulatory support for generics
Pharmacokinetics & Bioequivalence
- Bio‑Study Protocols & Planning – Strategic design of studies
- Bioequivalence Study Monitoring – Ensuring compliance & accuracy
- Regulatory Submission Support – Review & documentation of bio‑study reports
