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Comprehensive Safety Science and Clinical Consulting Services
At UNIQUE Pharma Science, we provide expert guidance in clinical trials, regulatory compliance, safety, and pharmacovigilance. Our consulting services are tailored for biotech and pharmaceutical companies, ensuring patient safety and the highest standards of efficacy through every stage
from Phase I to post-market surveillance.
Clinical Trial Services (Phase I–IV)
What We Do:
Our Clinical Trial Services are designed to support pharmaceutical and biotech companies through every stage of clinical research. We focus on providing expert insights, high-quality documentation, and continuous medical oversight to ensure your trials meet the highest standards of safety and efficacy. By using our extensive experience and expertise, we help our partners achieve successful clinical outcomes that lead to regulatory approvals and effective patient treatments.
We provide comprehensive support from Phase I to Phase III studies, including remote medical monitoring, safety evaluations, and build-up of strategies for core developmental documents: Protocols, Statistical analysis Plans (SAPs), Investigator's Brochures (IB), Informed Consent Forms (ICFs) and Clinical Study Reports (CSRs).
Our Services Include:
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Protocol Design: Creation of clear and measurable safety, efficacy, and exploratory endpoints to provide solid regulatory foundations.
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Risk Management System Creation and Implementation: Development of tailored systems to identify, mitigate, and monitor risks throughout the trial, complying with regulatory standards.
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Clinical Trial Signal Detection and Benefit-Risk Analysis: Management of signal detection processes, including DSC meetings and benefit-risk assessments to ensure participant safety.
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Expert Guidance for Core Documents: Guidance for high-quality Investigator's Brochures, and risk language in ICFs, SAPs, and CSRs, ensuring accuracy and regulatory compliance.
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Remote Medical Monitoring: Continuous monitoring throughout the study to detect safety issues early, mitigate risks, and support trial sites.
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Safety Reporting (DSURs and Line Listings): Comprehensive safety reporting for Developmental Safety Update Reports (DSURs) and periodic line listings, in accordance with global regulations.
Why it Matters:
Ensuring your study has well-designed endpoints and comprehensive safety measures is crucial to regulatory success. With our services, we work towards creating a solid foundation that meets marketing authorization requirements, while also ensuring participant safety and regulatory compliance throughout the study. Our expertise helps you make informed decisions, mitigating risks and navigating the complex regulatory landscape with confidence.
Partnering with UNIQUE Pharma Science for clinical trials means you get a partner focused on patient safety, efficiency, and proven outcomes at every phase. Our expert medical oversight helps to mitigate risk while optimizing study protocols for the best results
Post-Market Surveillance and Safety
What We Do:
Once a product has received regulatory approval, ongoing safety monitoring and compliance become essential to ensure its continued safe use. At UNIQUE Pharma Science, we offer comprehensive post-market surveillance and safety solutions to help maintain your product's safety profile and meet regulatory standards across all regions.
Our Post-Market Surveillance and Safety Services Include:
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Phase IV Studies and Post-Authorization Safety Studies (PASS): We develop strategies for conducting Phase IV studies, including post-authorization safety studies (PASS), to monitor the long-term safety and effectiveness of your product once it is on the market.
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Early Access Programs (EAPs) Protocol Development: We support the creation of protocols for Early Access Programs (EAPs), allowing patients to access potentially life-saving treatments while ensuring rigorous safety oversight.
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Complete Signal Management System: We provide full support in implementing a robust signal management system to detect, assess, and respond to potential safety signals, ensuring patient safety throughout the product lifecycle.
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Risk Management Systems (RMPs) for EU and RoW: We build and maintain comprehensive Risk Management Plans (RMPs) that comply with European Union (EU) and Rest of World (RoW) requirements, ensuring your product remains compliant with local regulatory authorities.
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Safety Reporting (PBRERs, PADERs): Our team is experienced in preparing and submitting Periodic Benefit-Risk Evaluation Reports (PBRERs) and Periodic Adverse Drug Experience Reports (PADERs), providing essential updates on the safety of your product to regulatory agencies.
Why It Matters:
Maintaining the safety of your products after they reach the market is vital for both patient safety and regulatory compliance. Without effective post-market surveillance, the potential risks associated with your product may go unnoticed, jeopardizing patient safety and regulatory status. Our comprehensive post-market services help you ensure your products remain safe for consumers, sustain compliance with regulatory authorities, and maintain public trust in your brand.
Regulatory Compliance and Filing
What We Do:
Successfully navigating the complex regulatory landscape is crucial for bringing products to market and maintaining their authorization throughout their lifecycle. At UNIQUE Pharma Science, we specialize in providing comprehensive regulatory support to ensure compliance with regional and global standards, covering the US, EU, China, Japan, and Rest of World (RoW) regions.
Our Regulatory Compliance Services Include:
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Preparation of Strategies for Integrated Safety and Efficacy Summaries (ISS, ISE): We provide expert guidance in preparing integrated summaries of safety (ISS) and efficacy (ISE), which are critical components of regulatory submissions, ensuring that data is presented cohesively and meets rigorous standards.
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eCTD Module 2 Preparation for Regulatory Filing: Our team specializes in preparing Module 2 of the electronic Common Technical Document (eCTD) for regulatory filings across EU, US, Japan, and RoW. This includes overviews and summaries that synthesize the entire submission, ensuring clarity and compliance with regulatory expectations.
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Responding to Regulatory Questions (EMA, FDA, PMDA, Health Canada): We manage responses to questions from key regulatory agencies, such as EMA, FDA, PMDA, and Health Canada, ensuring prompt and accurate information is provided to support your product’s path to approval.
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Oral Explanation Support: We provide strategic support and representation during oral explanations with regulatory agencies, helping to articulate key product benefits and address any concerns in a clear and professional manner.
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Company Core Data Sheet (CCDS) Updates: We assist in creating and updating Company Core Data Sheets (CCDS) to maintain consistent product information globally, ensuring all safety, efficacy, and prescribing information is up to date.
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SmPC, USPI, JPI, PM Updates: Our services include updates to Summary of Product Characteristics (SmPC), US Prescribing Information (USPI), Japanese Package Insert (JPI), and Product Monographs (PM), ensuring all regional documents reflect the latest safety and efficacy information.
Why it Matters:
Regulatory compliance and maintaining marketing authorization are some of the most significant hurdles faced by pharmaceutical companies post-development. Without the proper guidance, navigating local and global regulations can delay your product's journey to market. Our expert team ensures your submissions and regulatory responses are accurate, timely, and in full compliance with regional requirements, helping to minimize risks and achieve product success in the competitive pharmaceutical landscape.
Additional Safety and Regulatory Consulting Services
What We Do:
Ensuring the long-term safety of medicinal products is a complex, ongoing task. At UNIQUE Pharma Science, we offer a wide array of specialized safety and regulatory consulting services designed to cover all aspects of your pharmacovigilance system. Our expert team provides proactive support to keep your products safe and your company fully compliant with evolving regulations.
Our Additional Safety and Regulatory
Consulting Services Include:
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Development of Additional Pharmacovigilance Activities: We assist in designing and implementing additional pharmacovigilance activities to meet post-approval safety requirements and maintain a robust safety monitoring system.
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Risk Minimization Measures: We create, evaluate, and maintain additional risk minimization strategies tailored to your product's safety profile. This helps mitigate specific risks identified during the drug’s lifecycle, ensuring optimal patient safety.
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Pharmacovigilance System Master File (PSMF) Support: We provide expertise in the creation, maintenance, and periodic updates of the Pharmacovigilance System Master File (PSMF), ensuring all necessary safety data and regulatory requirements are up to date and accessible.
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Safety Data Exchange Agreements (SDEAs): We help develop comprehensive Pharmacovigilance and Safety Data Exchange Agreements (SDEAs), enabling smooth collaboration with external partners while ensuring proper reporting and safety management.
Why It Matters:
A strong pharmacovigilance system is not just a regulatory requirement; it is a cornerstone of patient safety and product integrity. By maintaining a well-designed pharmacovigilance infrastructure, you can be confident that your products remain safe and effective post-approval. Our expertise ensures that you are fully compliant with all regulatory expectations, helping your organization stay ahead of safety challenges while fostering trust with patients, healthcare professionals, and regulatory bodies.
Why Choose UNIQUE Pharma Science?
At UNIQUE Pharma Science, we are more than just a consulting service provider – we are your dedicated partner in bringing innovative medical solutions to life. Our mission is to help you meet patient needs effectively by offering tailored, cutting-edge strategies backed by years of scientific and regulatory expertise.
Our Key Strengths Include:
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Patient-Centric Approach: Every decision and strategy we implement is driven by a deep commitment to patient safety and well-being.
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Innovative Solutions: We utilize innovative methodologies to navigate complex clinical trials, regulatory challenges, and post-market requirements, ensuring your product journey is streamlined.
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Expert Team: With extensive experience across the fields of medical, scientific, and regulatory consulting, our team delivers exceptional guidance to achieve the best outcomes for your projects.
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Regulatory Compliance: We ensure your treatments meet the highest safety, efficacy, and regulatory standards across all regions, from clinical trial phases to post-market surveillance.
Let UNIQUE Pharma Science help you bring safe, effective, and transformative treatments to patients worldwide. Partner with us for a journey marked by scientific excellence, patient safety, and success in every project phase.
FAQs Related to Our Services
Q1: What is pharmacovigilance, and why is it important?
A: Pharmacovigilance is the process of monitoring the safety of drugs after they have been approved for market use. It involves identifying, assessing, and preventing adverse effects or any other drug-related problems. This process is crucial in ensuring that medicinal products remain safe and effective for patients throughout their lifecycle. Our team at UNIQUE Pharma Science provides comprehensive pharmacovigilance services, ensuring all products adhere to stringent safety standards.
Q2: How do your clinical trial consulting services differ from others?
A: Our clinical trial consulting services are tailored specifically to each client’s unique needs. We assist from Phase I to Phase IV, providing support such as medical monitoring, regulatory guidance, and safety oversight. We focus on precision and customization, ensuring each clinical trial is efficient, safe, and compliant with global regulatory standards. Our experience with international regulations ensures a streamlined path from clinical trials to market approval.
Q3: Why is regulatory compliance crucial for pharmaceutical companies?
A: Regulatory compliance ensures that a pharmaceutical product meets all the safety, quality, and efficacy standards set by authorities such as the FDA, EMA, and other regional bodies. It is crucial to navigate these regulations effectively to bring your product to market without unnecessary delays or complications. Our expertise helps pharmaceutical companies meet regulatory requirements smoothly, ensuring a higher probability of approval across different markets.
Q4: What are Early Access Programs (EAPs), and how can they benefit patients?
A: Early Access Programs (EAPs) allow patients with serious conditions to access potentially life-saving medications before they are fully approved. These programs can provide hope and treatment options to patients who may have no other alternatives. At UNIQUE Pharma Science, we help clients develop protocols for EAPs to ensure compliance while providing valuable treatments to those in need.
Q5: What does post-market surveillance involve, and why is it necessary?
A: Post-market surveillance involves monitoring the safety and efficacy of a pharmaceutical product after it has been approved for use. This process helps detect any rare or long-term side effects that may not have been apparent during clinical trials. We offer services like signal detection, risk management, and periodic safety reporting to ensure your products remain safe, compliant, and effective throughout their lifecycle.
Q6: How do you ensure successful risk management during clinical trials?
A: Successful risk management during clinical trials involves identifying potential risks early and implementing mitigation strategies to address them. Our team supports clients with the development of Risk Management Plans (RMPs), Benefit-Risk Analysis, and Drug Safety Committee (DSC) meetings. By proactively managing risks, we ensure smooth progress of clinical trials and a higher chance of regulatory approval.
Q7: What is the role of a Drug Safety Committee (DSC)?
A: A Drug Safety Committee (DSC) plays a critical role in overseeing the safety aspects of clinical trials. The DSC evaluates safety data during the trial, recommends changes to protocols if necessary, and ensures that participant safety remains the highest priority. At UNIQUE Pharma Science, we provide expert guidance and coordination for DSC meetings to ensure the safety of trial participants.
Q8: How do you assist with Regulatory Filing and Submissions?
A: We assist our clients by preparing eCTD modules, developing Integrated Safety and Efficacy Summaries (ISS, ISE), and providing support in answering regulatory queries. Our experience spans various regulatory bodies, including the FDA, EMA, PMDA, and more, which ensures that your submissions meet all necessary standards and requirements.
Q9: What are Signal Management Services?
A: Signal management involves detecting, assessing, understanding, and managing potential safety signals related to pharmaceutical products. Our team is experienced in providing comprehensive signal management services, ensuring that safety signals are properly identified, evaluated, and communicated to the relevant regulatory authorities.
Q10: What is a Risk Management Plan (RMP), and why is it essential?
A: A Risk Management Plan (RMP) outlines the activities to identify, characterize, prevent, or minimize risks related to a medicinal product. It is essential for maintaining the safety of products throughout their lifecycle. At UNIQUE Pharma Science, we develop and implement RMPs to ensure that your products comply with regulatory standards and are safe for patients.
What our Client say
Jeniffer Ross,
Their risk management strategies were instrumental in navigating potential challenges, paving the way for our project's success.
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