Callidus Labs provides specialist product modification and reformulation services to satisfy the market's changing demands. Cost-cutting measures and regulatory changes may necessitate the enhancement of current items. Our strategy entails a thorough examination of the existing formulation, the identification of particular difficulties, and the provision of effective remedies, followed by a smooth technology transfer to the manufacturing site.
Callidus has a cutting-edge R&D facility that spans 20,000 square feet (1860 square meters), is built to international standards. Our extensive reformulation development lab is intended for a variety of dosage forms, allowing us to meet a wide range of requirements.
We provide a variety of reformulation services, including:
- Alternate API Source Development: alternate API Source Development entails identifying alternate sources for Active Pharmaceutical Ingredients in order to maintain a consistent supply chain.
- Yield Improvement: Improving production yield in order to maximize resources and minimize expenses.
- QBD Principles in Action: Implementing Quality-by-Design ideas throughout the reformulation development process.
- Product Shelf Life Improvement: Improving the lifetime of items in order to boost their commercial viability.
- Cost Reduction: Cost-cutting measures include identifying possibilities to reduce manufacturing costs while preserving product quality.
- Key Excipient Replacement: Finding acceptable alternatives for important excipients with vendor supply restrictions.
State-of-the-Art Infrastructure and Expertise
Our strength comes from our cutting-edge infrastructure and expertise:
1. Services for Specialized Reformulation Development
Our scientists and specialists have decades of expertise in the pharmaceutical sector and can help you design reformulations. We offer cutting-edge technology and services to help your company grow from concept to commercialization.
2. Management of Intellectual Property and Regulatory Compliance
We make certain that all reformulation plans adhere to intellectual property and legal standards. To optimize outcomes, Quality-By-Design (QbD) ideas are included throughout the reformulation development process.
3. Formulation Development Excellence
We excel in all elements of formulation development, with an emphasis on pre-formulation, reformulation development, analytical technique development and validation, stability studies, and technology transfer. Our compliance with regulatory criteria ensures the highest quality standards.
Uncompromising Focus on Quality
At Callidus, quality is at the heart of everything we do. We are big believers in reaching excellence via thorough preparation rather than by coincidence. Our strong devotion to proper documentation processes guarantees that quality always comes first.
Quality Assurance Measures
We have put in place stringent quality assurance measures, such as:
- Comprehensive Standard Operating Procedures (SOP)
- Extensive Guidelines and Training Programs
- Documentation Management
- Change Management
- CAPA (Corrective and Preventive Actions) Management
- Master Site Plan
- Programs for Equipment/Instrument Qualification and Calibration
Adding Value to Your Products
Our commitment to offering services of the highest quality adds substantial value to our client's existing product selection. We can help you thrive in the changing pharmaceutical business by transforming your ideas into marketable, FDA and EMEA-compliant medicines using our knowledge in reformulation development. Callidus Labs is your trusted partner for all your reformulation needs, whether they be cost reduction, yield improvement, or product shelf life extension.