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Formulation Development Services
Formulation Development Services
Comprehensive Support for High-Quality Product Development
At Isha’s GMP Services, we specialize in delivering cost-effective, high-quality formulation development with a focus on compliance, efficiency, and innovation. Our expertise spans pre-formulation, process development, analytical validation, and regulatory support, ensuring successful product development and commercialization.
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 – Developing stable and effective formulations
- Packaging Development – Selecting suitable primary & secondary packaging
- Process Development & Optimization – Ensuring efficient manufacturing
- Scale-Up & Technology Transfer – Seamless transition from lab to production
- Process Validation Studies – Ensuring 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 generic formulations
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
Why Choose Isha’s GMP Services?
- Industry expertise with global regulatory compliance
- Cost-effective and time-efficient solutions
- End-to-end support for seamless development & commercialization
- Strong focus on quality, innovation, and compliance
Get in touch today to accelerate your formulation development process!