Formulation Research and Development Services
Your Trusted drug product development Partner, At Callidus Research Laboratories, we take pride in offering extensive and cutting-edge formulation development services to meet the diverse needs of our valued clients. Whether you require formulations for generics, New Molecular Entities (NMEs), Over- The-Counter (OTC) products, or Veterinary formulations, we have got you covered with our wide array of capabilities.
The expert team of scientists at Callidus Research has extensive experience working in pharmaceutical research and development thus Our expertise will help clients to achieve their drug product development goals.
Step into our State-of-the-Art Formulation Development Laboratory, where innovation meets efficiency, and experiences a fast-track drug product development. With cutting-edge technologies and a dedicated team, we specialize in shortening timelines, helping you bring life-changing medications to market with greater speed and precision.
With our comprehensive services, fortified by robust in-house expertise in analytical method development and ICH-compliant real-time/accelerated stability studies we help you to unlock the full potential of your formulation development. We ensure that your products meet the highest standards of quality, safety, and efficacy, empowering you with reliable data and accelerated timelines for a successful market launch.
At Callidus Research Laboratories, we excel in handling controlled substances with precision and compliance. Our experienced team develops pharmaceutical products with strict adherence to regulations, ensuring safety and efficacy. With a strong commitment to quality and innovation, we deliver compliant solutions in the pharmaceutical industry.
With cutting-edge capabilities to develop products containing both non-high potent and potent compounds, our expert team can handle all your formulation needs with precision and excellence.
From pre-formulation to analytical development studies, drug delivery system design, stability evaluation, prototype preparation for in vitro and in vivo studies, reformulation, and technology/site transfer – our comprehensive services cover every aspect of your pharmaceutical development journey.
At Callidus Research Laboratories, Quality-By-Design (QbD) is ingrained in every stage of formulation development. Our scientists leverage QbD tools and Design of Experiments (DOE) along with risk assessment strategies to design comprehensive experimental plans.
Our goal is to create a robust formulation and process for your product, streamlining the path to regulatory approval and commercialization. Empowered with state-of-the-art equipment and instruments for formulation development and analysis, we facilitate the development of diverse dosage forms, spanning oral administration and parenteral delivery.
Different types of formulation research and development services Callidus offers
Pharmaceutical formulation development demands a multidisciplinary approach, encompassing pre- formulation studies, formulation design, process development, pharmaceutical stability testing, as well as intellectual property and regulatory compliance. At Callidus Research Laboratories, we offer all these essential formulation development services to cater to the unique needs of our valued customers
At Callidus, we understand the client's need to develop robust, bioequivalent formulations as per regulatory requirements.
We offer the following formulation development services
- Formulation development as per QBD (using DOE) for NME’s, Generics, 505B2, Differentiated
- formulation, OTC’s and Veterinary products
- Formulation development for early safety studies
- Screening study of the prototype formulations
- Formulation & process optimisation
- Product improvement services
- Technology transfer services
- Container-closure compatibility and selection
- Assessment of product shelf life via accelerated and real-time stability
- Drug Delivery Technologies we practice.
Tablets
- Immediate Release Tablets
- Delayed Release Tablets
- Sustained/Prolonged/ Controlled Release Tablets
- Orally Disintegrating Tablets
- Bi-layered Tablets
- Chewable Tablets
Powders
- Parenteral Lyophilized powders
- Taste-masked dispersible/or dispersible powders
- Effervescent granules
- Powders & granules for reconstitution
Capsules
- Granules/powder filled into hard gelatine capsules
- IR, ER and SR Pellets filled into hard gelatine capsules
- Mini tablets filled into hard gelatine capsules
Semi Solids
- Gels
- Creams
- Ointments
Injectables
- Solutions
- Suspensions
- Emulsions
- Powders
- Lyophilized powders
Ophthalmics
- Solutions
- Ointments
- Suspensions
- Gels
Manufacturing technologies we practice
The development facility of Callidus is equipped with all the latest & state-of-the-art equipment to execute drug product manufacturing technologies like:
High shear wet granulation
Dry granulation by roller compaction
Fluid bed processing including Wurster and top-spray granulation
Direct compression
Bilayer tablet compression
Extrusion spheronization
Film Coating using perforated auto coaters
Capsule filling like powder, pellets, and granules
Fixed isolators for handling highly potent/ hormonal/ anticancer products
Lyophilizer for handling lyophilized oral & parenteral products
Infrastructure to achieve % Humidity below 20 % RH for handling of effervescent products and moisture sensitive API’s.
At Callidus, our formulation development study follows a quality-driven approach, seamlessly transitioning to the scale-up process. Once a target formulation is chosen, we meticulously scale it up while preserving critical product attributes.
We prioritize our clients' budgets and investments, delivering cost-efficient solutions tailored to their specific drug formulation needs. Backed by a solid regulatory foundation, our scientists boast a track record of successfully bringing drug products from the bench to market. Trust us to be your reliable partner in realizing pharmaceutical success.
