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PROTOCOL DESIGN
The complexity and demands of protocols have increased in recent years.
That complexity is putting a burden on patients and investigators alike and can heavily impact patient enrollment rates.
Yet amending protocols mid-stream will noticeably increase the time and cost of the development program with no guarantee of outcome improvement.
Chemistry, Manufacturing and Controls (CMC)
All stages of the drug development life cycle, after drug discovery involve CMC.
During preclinical drug development, the proper analytical methods are validated to monitor the product. Stability testing may be initiated, the physicochemical properties of the product are determined, raw materials are chosen and tested.When the drug development process moves into the clinical stage, further analytical method validation is required, and additional characterization of the drug product is needed.
After clinical trials the scale-up process must ensure that the larger batches of product are the same and meet the same specifications as the drug tested in the clinical trials, and after the manufacturing process is qualified, lot release and in-process testing will continue to take place.
Pharmacodynamics (PD), Pharmacokinetics (PK), and Toxicokinetics (TK)
Non-clinical Pharmacodynamic (PD), Pharmacokinetic (PK) and toxicokinetic (TK) analyses are key activities of early drug development, but that does not mean their importance fades after Phase I initiation.
Extensive and formalized PD, PK and TK studies with GLP compliance form the basis of proving drug efficacy and continued success, as well as exploring possible different clinical approaches, such as the route of administration.
We can help streamline the process with:
PK Sample Analysis
Rapid PK Screening
ELISA Assays
Analysis of Optimal Dosing Regimen
Laboratory Solutions
Laboratory Solutions streamline research processes, offering tailored tools and services to enhance efficiency and quality. From sample analysis to data management, these solutions optimize workflows and drive innovation in drug development and clinical research.
Biostatistics
Biostatistics and offer more than statistical analyses. Our understanding of the science of disease and biologics, as well as knowledge of valuable upfront study design and comprehensive planning assistance.
Investigator payments/Contract management
Timely and accurate Investigator payments are critical for keeping sites motivated and driving site performance in a study. Study protocols have become more complex, and the invoice process and tax management for sites further complicates the task of making timely and accurate payments.
Patient Centered Services
It is critical to understand the needs and key decision-making considerations of the target patient population, as this understanding allows the leverage patient perspective to optimize feasibility, recruitment and retention.
This enables the development of highly effective, focused strategies that increase engagement throughout the patient’s journey.
Site Support/Startup
A clinical site requires a surprising amount of support that is not immediately evident. Its infrastructure needs to be documented to the satisfaction of regulatory authorities, and encompasses a wide array of subtopics, including equipment and information storage, system controls, blinding, data transparency, data sharing, record keeping, physical and digital security, technological capabilities, hiring processes, conflicts of interest, operational infrastructure, maintenance, among others.
Additional requirements include safety reporting, preventive and corrective actions, participant engagement, risk/benefit communication, informed consent, participant welfare, IRB approval.
Customized Solutions
All our solutions are built on the belief that everything should be agile and customized. Our products can always be quickly tailored to the demands at hand.
Regulatory Support
A regulatory plan devised early in product lifecycle is a powerful, strategic tool to preemptively identify key challenges that may arise, as well as a guideline for constant communication and interaction with relevant regulatory bodies.
Navigating this complex landscape ensures the investigational product aligns with regulatory and commercial requirements, but is far from easy.
Bioanalysis
Solid bioanalytic capabilities are indispensable when trying to obtain precise results, and precise results are precisely what regulatory bodies wish to see in a submission.
Screening & Profiling Assays
Assay development is an indispensable aspect of proving the validity of IND-enabling studies.
A custom assay, or an expert evaluation of your own assay before screening begins is a critical safeguard against denial from regulatory authorities.
Pharmacology & Toxicology Studies
Assessing drug profiles early in the development cycle is key to avoiding wasted research, and to progress from discovery stage through to IND stage, as toxicity is the primary reason a drug is not approved for Phase I clinical trials.
Laboratory Solutions
Laboratory Solutions streamline research processes, offering tailored tools and services to enhance efficiency and quality.
From sample analysis to data management, these solutions optimize workflows and drive innovation in drug development and clinical research.
Cell Sourcing
Cell sourcing is the crucial process of obtaining cells for research or therapy. Only a quality source can ensure suitability for various applications in biotechnology and medicine, and we pride ourselves on having some of the best.
Phase II+
The difficult part of drug development doesn’t end after Phase I, and in fact is just the beginning. Regulatory bodies have increasingly higher standards the closer to final marketing approval the investigational product is.
Furthermore, the cost of studies rises exponentially with each passing clinical phase, lowering the leeway for mistakes. A competent regulatory and scientific team is thus mission-critical to continued development and ultimate success.
IND Submission
Together, we can:
Eliminate regulatory pitfalls
Keep development on track
Ensure appropriate strategy at each step
Structured data management
Additionally, we also offer a full-service IND strategy, where our guidance spans the entire drug development process, ensuring a flexible and agile approach where solutions are tailored and streamlined to meet individual project needs.
For this, our solutions include:
Fact-based decisions to improve probability of success and regulatory approval
Risk analysis and mitigation, both regulatory and operational
Regulatory strategy consulting is essential for navigating the intricate regulatory landscape of the pharmaceutical and biotech industries. Expert consultants provide guidance on developing tailored strategies to expedite product approval processes, ensure compliance with regulations, and optimize market access.
From early-stage planning to post-market support, regulatory strategy consulting ensures companies meet regulatory requirements efficiently, enabling them to bring innovative therapies to market swiftly and effectively.
Asset Development
All but the largest biotech companies face considerable drug development challenges, as they often need to keep teams small and agile enough to maintain a competitive and innovative edge. Further, they are faced with resource constraints and will likely encounter a problem that cannot be addressed with in-house capabilities. Worse, they have a lack of trustworthy partners to confide in their intellectual properties (IP).
Through YC Biotech’s end-to-end solutions, we can simultaneously ameliorate all these concerns and ensure a smooth transition from preclinical to IND.
