Our Services
Accelerating Your Pharmaceutical Success
Comprehensive Formulation Development
We expertly craft formulations, encompassing pre-formulation, QbD strategies, and diverse dosage forms (oral solids, injectables, powder inhalers). Our cGMP-compliant pilot batch manufacturing guarantees quality at every stage.
Scale-Up and Optimization
Seamlessly transition your formulations from the lab to production scale. We specialize in cGMP-focused processes for domestic markets and offer process enhancement support for various dosage forms, optimizing efficiency and cost-effectiveness.
Robust Analytical Development
Maintain product quality and integrity with our full suite of analytical services: method development, validation, transfers, and comprehensive stability studies – all designed for regulatory compliance.
Project Execution & Compliance
Achieve milestones with our expert project management. From initiation to completion, we ensure regulatory adherence, data accuracy, and proactive resolution of challenges keeping your project on track.
BA/BE Studies Oversight
We meticulously oversee your bioequivalence and bioavailability studies for guaranteed regulatory compliance and reliable data you can trust.
Innovation & Process Optimization
Streamline manufacturing, enhance technology transfers, and boost product quality with our process optimization expertise.
Reverse Engineering for Quality Assurance
We analyze and reproduce products through reverse engineering, ensuring your existing products meet the highest quality standards.
Validation and Stability Studies
Meticulous validation and stability studies underpin your product development efforts, providing the robust data needed for both innovation and compliance.
Emphasize time and efficiency. focusing on cost savings and quality.
Quality-Driven Development: Streamlined, Cost-Effective, Compliant
Our integrated services and experienced team accelerate your drug development timeline. We optimize processes, anticipate challenges, and work with a sense of urgency to deliver your product to market swiftly.
With our deep expertise and strategic approach, we eliminate redundancies and costly delays. Our goal is to reduce your development expenses without compromising quality or compliance standards.
FAQ
What types of pharmaceutical services do you offer?
We provide a comprehensive suite of services including formulation development, analytical development, project management, BA/BE studies oversight, regulatory consulting, and more.
How do you ensure the confidentiality of my project?
We take client confidentiality very seriously. We implement strict non-disclosure agreements (NDAs) and have secure data management systems in place.
What is your typical project timeline?
Project timelines vary depending on complexity. However, we are committed to working efficiently and transparently to meet your target dates.
What is the best way to get started with your services?
Contact us directly to discuss your specific project needs. We’ll be happy to provide a personalized consultation.
Do you have experience working with international regulatory agencies?
Yes, we have a proven track record of assisting clients in navigating the regulatory landscape in North America, Europe and ASIA.
Can you help with both generic and new drug development?
Yes! Our expertise encompasses both generic formulation development and the rigorous processes required for new drug innovation.
Do you offer customized service packages?
Yes, we understand that each project is unique. We work with you to tailor a service package that aligns with your goals and budget.