Calatheas Consulting
We Offer a Range Services to Meet Your Needs
Experience in Generic Formulation Development for Regulated Markets
Calatheas Solutions boasts a wealth of experience in developing generic pharmaceutical formulations tailored to meet the rigorous standards of various regulated markets. Our global reach extends to the United States, Europe/UK, Australia, Canada, Brazil, China, and other regions, enabling us to navigate the complexities of each market efficiently and effectively.
Sound Knowledge of Intellectual Property Rights and Quality-by-Design (QbD):
Our team possesses a deep understanding of Intellectual Property Rights (Patents) and applies this knowledge strategically in our Product Development processes. We employ Quality-by-Design (QbD) principles to ensure that our products are not only compliant but also optimized for quality, safety, and efficacy.
Expertise in Product and Process Development:
Calatheas Solutions excels in Product and Process Development, with a focus on optimization, scale-up, and validation. We have successfully executed numerous projects, covering a wide range of pharmaceutical forms, including Solid and Liquid Oral formulations, as well as Topicals.
Interpretation of Pharmacokinetics and In-Vitro Dissolution:
Our team includes experts who specialize in interpreting pharmacokinetic data and in-vitro dissolution studies. This expertise is particularly crucial in the context of Bioequivalence Studies, where we excel in designing and evaluating protocols to ensure successful outcomes.
Regulatory Compliance and cGMP Expertise:
We maintain a strong understanding of Regulatory requirements, cGMP (current Good Manufacturing Practices), and Compliance standards for the United States and other Regulated markets. Our commitment to upholding these stringent requirements ensures that our clients can trust the quality and reliability of our formulations.
Comprehensive Formulation Development Services:
Calatheas Solutions offers end-to-end services in Formulation Development, encompassing all aspects of the process. From initial evaluation and development to scale-up and manufacturing of formulations for pilot and clinical studies, we ensure that every project aligns with current regulatory, GLP (Good Laboratory Practice), and GMP requirements while adhering to a well-defined patent strategy.
Training & Development
Calatheas Consultancy specializes in streamlined Training and Development programs designed for the pharmaceutical industry, with a focus on Research and Development (R&D), Manufacturing, and Sales. Our succinct yet comprehensive modules equip professionals with the latest industry insights, cutting-edge methodologies, and practical skills necessary for success in their specific roles. Elevate your teams with Calatheas Consultancy's tailored training, fostering a workforce that excels in navigating the intricacies of R&D, manufacturing processes, and sales strategies. Trust us to empower your professionals for enhanced productivity and success in the competitive pharmaceutical landscape.​
Technical Writing & Documentation
Calatheas Consultancy excels in crafting essential documents, including Pharmaceutical Development Reports, ANDA (Abbreviated New Drug Application), and controlled correspondences. Our experienced team ensures meticulous and detailed Pharmaceutical Development Reports, highlighting critical aspects of drug development. We provide end-to-end support for ANDA submissions, optimizing documents for regulatory approval. Controlled correspondences are handled with precision, ensuring effective communication with regulatory agencies. Choose us for a holistic approach, streamlining your documentation for regulatory success.​
Bioequivalence Expertise:
Our team specializes in creating bioequivalence protocols and evaluating the outcomes of bioequivalence studies, a critical aspect of ensuring the marketability of generic pharmaceutical products.
Nitrosamine impurity:
At Calatheas Consultancy, we specialize in addressing nitrosamine-related challenges in commercial products with a focus on preserving existing processes and formulations. Our expertise lies in devising effective solutions that allow for the resolution of nitrosamine issues without necessitating major changes. This strategic approach is designed to minimize disruption, ensuring a smooth and efficient path to market delivery.
Our seasoned team is adept at navigating the complexities associated with nitrosamine concerns, employing innovative strategies to mitigate risks and uphold product integrity. By leveraging our expertise, clients can confidently bring their pharmaceutical products to market without undergoing substantial alterations to their established processes and formulations.
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Intellectual Property and Strategic Advisory Services
Our company specializes in providing comprehensive intellectual property (IP) and strategic advisory services to clients across various industries. With a team of experienced professionals, we offer a wide range of services aimed at protecting and maximizing the value of your intellectual assets while helping you navigate the complex landscape of IP and market opportunities.