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 diverse needs of our valued clients. Whether you require formulations for New Molecular Entities (NMEs), Generics, Over- The-Counter (OTC) products, or Veterinary, we have got you covered with our wide array of capabilities.

The team of scientists at Callidus Research has extensive experience 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 Drug Substances, Anti-Cancer Drugs, Steroids and Harmons 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 high potent compounds, our expert team can handle all your formulation needs with 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.

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 unique needs of our valued customers

At Callidus, we understand client's need to develop robust, bioequivalent formulations as per regulatory requirements.

Formulation Research and Development Services:

Drug Delivery Technologies We Practice:

Tablets

Capsules

Powders

Semi Solids

Injectables

Ophthalmics

Supporting Pharmaceutical Innovation with Technology Transfer

Callidus Research Laboratories, your dedicated partner in pharmaceutical drug product development and innovating groundbreaking technologies is conscious about the importance of technology transfer in the success of any product.

Our expertise lies in transferring technology and knowledge to our client, empowering them to efficiently manufacture drug products.

Callidus believes that successful technology transfer is critical, so it ensures systematic transfer of scientific information from its development side (knowledge center) to the receiving side (manufacturing plant).

Callidus Research Labs takes pride in supporting its customers by offering end-to-end support, the formulation and analytical scientists from Callidus can present at the manufacturing site for seamless execution of analytical method transfer, scale up and dossier submission batches manufacturing.

As a preventive measure, analytical scientists can also be present during each analysis of submission batch samples on a need basis in order to ensure that there are no issues during stability analysis so as to prevent any delays in dossier filing.

Key Steps in the Technology Transfer Process

Preliminary Tech Transfer Dossier Preparation- We kickstart the process by meticulously preparing pre- tech documentation, encompassing manufacturing guidelines, specifications, standard testing procedures (STPs), transfer protocols, stability study and sampling protocols. This comprehensive dossier is then handed over to manufacturing site, laying groundwork for successful technology transfer.

Procurement Phase- Ensuring a smooth procurement phase is crucial for the tech transfer process. Callidus takes charge of procuring and receiving raw materials (RMs) and packaging change parts, as well as columns and reagents required for scale-up and process validation batches at the manufacturing site.

Site Transfer Phase- During this phase, we conduct a thorough review of all Contract Manufacturing Organization (CMO) documents to ensure compliance with product quality and regulatory requirements. Our meticulous approach helps in aligning all aspects with the highest industry standards.

Finished Product Method Transfer, Scale-Up Batch Manufacturing and Report Finalization- We facilitate the execution of finished product method transfer, and scale-up batches at the manufacturing site and assist in the preparation and review of the scale-up summary report. This ensures that the production process adheres to predefined protocols and produces consistent results.

Process Validation Phase- Ensuring the preparation of validation batch documentation at the manufacturing site is a critical step in the technology transfer process. Callidus actively reviews validation batch documents, provides necessary assistance, and oversees the execution of validation batches as per the defined protocols.

Evaluation of Stability Reports- As part of our commitment to seamless technology transfer, our analytical scientists may be present during the stability analysis of dossier submission batches at various time points. This enables us to verify and maintain the integrity of the transferred technology throughout the stability evaluation process.

Technology Transfer Approach

Callidus employs a comprehensive approach to technology transfer that takes into account several crucial factors:

Identifying Appropriate Technology and Equipment- We thoroughly assess the existing technology and equipment at the client’s manufacturing site while identifying any additional equipment or processes required for specific drug manufacturing. This enables us to create a tailored technology transfer plan for each client.

Establishing a Detailed Process Flow Diagram- A clear and detailed process flow diagram is fundamental for understanding the drug manufacturing process and ensuring consistent production of drugs to meet quality standards. Callidus collaborates with clients to develop a robust process flow diagram that guides the entire technology transfer process.

Developing Process Control Strategies and Analytical Methods- Process control techniques and analytical methodologies are critical for obtaining the target medication quality and ensuring consistency in the manufacturing process. Callidus collaborates extensively with clients to develop these strategies and approaches prior to technology transfer.

Training Personnel- We give full training to client staff, familiarizing them with the production process as well as any new equipment or technology being transferred. This guarantees that the client's facility runs smoothly and efficiently.

Providing Documentation- For successful technology transfer, detailed documentation, such as process flow diagrams, standard operating procedures (SOPs), and training materials, is required. Callidus guarantees that the required paperwork is supplied to the customer, promoting the use of standard operating procedures.

Validating the Process- Process Validation is an important stage in verifying the manufacturing process's capacity to reliably generate pharmaceuticals that fulfil the needed quality requirements. To validate the technology transfer process, Callidus undertakes extensive process qualification and validation studies.

Start Your Technology Transfer Journey with Callidus Labs

At Callidus Labs, we take pride in our well-planned and implemented technology transfer procedure, which enables our pharmaceutical clients to produce their products effectively and consistently. We ensure that our clients' aims of bringing novel pharmaceuticals to market are met by a team of competent scientists and a holistic strategy. Please contact us right away to begin a smooth and effective technology transfer for your pharmaceutical goods.

At Callidus, we don't just facilitate technology transfer; we empower transformations. Our commitment to excellence, innovation, and collaboration propels us to redefine the landscape of pharmaceutical technology transfer. Join us on this exhilarating journey as we craft a future where ideas seamlessly evolve into solutions that touch lives across the globe.