COMPREHENSIVE SOLUTIONS FROM LABORATORY DEVELOPMENT TO REGISTRATION OF NEW-GENERATION DRUGS WITH NO CLOSE ANALOGUES IN TERMS OF THERAPEUTIC EFFICACY, INTRODUCING A SERIES OF FORMULATIONS TO THE GLOBAL MARKET FOR THE FIRST TIME.
Strategic solutions in the early discovery phase of drug series development preceded by a technological potential of a Swiss holding company and Cyclolab having professional expertise in R&D.
In order to achieve strategic superiority, we adopted an integrated solution approach “If there is a disease, a new generation of customized APIs must be released to provide an effective and safe therapy”.
For the first time in the world, disease-specific APIs have been developed and launched in accordance with the requirements of pharmaceutical processes. Cyclolab demonstrates practical achievements of these effective formulations, which have been developed in parallel with preclinical studies.
Cooperation starts with the step of demonstrating evidence-based assurances, i.e. substantiation of non-analogous advantages of therapeutic products comparative to the TOP APIs of the marketed drugs.
In partnership with the CRO and the Customer, the next step is preparing the CTA application for regulatory approval to conduct clinical trials of all phases.
Cyclolab fully supports the CRO with our pharmaceutical technology expertise.
Clinical trials of all phases will be conducted with the involvement of the CRO, specialists and owner of the pharmaceutical technology, offering therapeutic techniques and guaranteed results.
A – conducting assessments on safety, efficacy, optimal dosages and design of trials based on clinical, post-clinical practice of exclusive medical methodologies.
B - statistical analyses using bioanalytical methods focused on plasma bioanalytics, where the exclusivity of our techniques enables the detection of API components in nanogram/mL concentrations. Our comprehensive support during clinical trials ensures predictable success and guaranteed results.
Offering drug development processes, scale-up of drug release, process validation, quality control, and other aspects.
Provided turnkey solutions ensure that the final product complies with regulatory and commercial production standards. It is recommended to use Cyclolab's facilities for both injectable and non-injectable dosage forms to accelerate the timeline. Technology transfer runs parallel to clinical trials, concluding no later than the end of Phase 3.
Cyclolab - will provide guaranteed "turnkey" implementation of the technology for compliance of the final product with regulations and standards for commercial production.
For more than 50 years our company has been specializing in scientific laboratory development, industrial production of new generation exclusive APIs, analytics of TOP-APIs existing on the market, their combination in formulation improvement, and R&D - consulting.
Although we do not commercialize drugs, we offer strategic and analytical insights into the global market potential of APIs, providing valuable market forecasts.
1. Pre-registration.
Complete the application form, select the disease, forms of drug use, and authenticate yourself. We will then provide analytical data covering the key aspects of:
• safety;
• efficacy;
• economics;
• timelines;
• market exclusivity potential.
Pre-contractual cooperation.
Upon your decision to continue the pre-contractual cooperation with us, registration is required. Respectively, please go through the procedure to receive a preview of the Investigator's Brochure including analytics and economic calculations of commercialization.
We will provide: the non-closed part of the IMPD, the Investigator's Brochure, as well as contracts, agreements between the “Parties”.
Final agreement.
Based on your decision to finalize the contractual agreement with us, it will include:
• drug registration services;
• technology transfer;
• guaranteeing exclusive API components for drug formulation;
• strategic guarantees from all parties on our cooperation's key aspects.
For your convenience, we offer you to get familiar with the application options prior to the registration, where you can select the nosologies of interest. In order to make a conscious decision on our pharmaceutical technology processes and commercial aspects, visit our nosology specific pages, filling out the Application Form.
Upon the filling out of the required Application Form, the customer can expect detailed analytics of evidence materials from pre-clinical to post-clinical phases, as well as analytical reports with an offer of possible cooperation.
Offering unique solutions from the drug discovery phase, featuring exclusive releases of cyclodextrins and other top API components. For the first time in the world, pharmaceutical formulations enable therapeutic synthesis of reactive oxygen species (ROS) within the body. These formulations offer complete safety and unmatched therapeutic efficacy.
Our services span from preclinical development to drug registration allowing a new-generation of drug formulations with guaranteed patent exclusivity. Cyclolab provides personalized R&D services, tailored a agreement between two parties, ensuring expert consultation and successful drug registration.
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