SERVICES
Pharmacovigilance
We are a premier provider of regulatory affairs, pharmacovigilance, dossier preparation, quality assurance and training services.
Training and workshops
Ensure compliance and enhance expertise with our customized on-site pharmacovigilance training. Our programs cover all aspects of PV and drug safety, tailored precisely to your specific requirements. Targeted workshops allow focused learning on key areas, empowering your team to make effective contributions to medicinal product safety. Invest in the highest standards of compliance and vigilance for your organization. Contact us today for tailored pharmacovigilance training.
Aggregate reports and Regulatory Documents writing
We provide high-quality regulatory document writing services that encompass a wide range of regulatory documents and aggregate reports. Our services cover Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Periodic Adverse Drug Experience Reports (PADERs). With meticulous preparation, comprehensive medical review, and timely submission, we ensure full compliance with intricate requirements, whether it’s compiling crucial information for DSURs or preparing PSURs for the EMA and/or PADERs for the FDA.
Other reports include but not limited to:
- Pharmacovigilance System Master File (PSMF)
- Pharmacovigilance System Summary (SPS)
- Standard Operating Procedures (SOPs)
- Policies and guidelines
We ensure that these documents are crafted with excellence and meet all regulatory standards.
Literature monitoring
Risk-Benefit evaluation and development of safety specification
We specialize in offering strategic guidance for the analysis of safety data across a broad spectrum of medicinal products, including generics, innovative molecules, biosimilars, and advanced therapy medicinal products (ATMPs). From clinical studies to post-marketing data assessment, our expertise ensures comprehensive risk management for all product categories.
Our services encompass two vital components:
Risk Management Plan (RMP):
- Identifying and Describing Safety Profile: Assessing known risks and potential adverse effects.
- Planned Pharmacovigilance Activities: Outlining activities for understanding existing and emerging risks.
- Post-Marketing Approval Requirements: Addressing regulatory requirements after marketing authorization.
Risk Evaluation and Mitigation Strategy (REMS):
- Evaluating effectiveness of planned pharmacovigilance activities.
- Preparation of REMS documentation.
- Liaising with the core team on REMS strategy
- Development and design of REMS materials
Development of Safety communication
Our company specializes in providing a comprehensive service for safety communication development, covering key components such as the Summary of Product Characteristics (SmPC), United States Prescribing Information (USPI), Patient Information Leaflet (PIL), and Patient Wallet Cards. We understand the importance of these materials in effectively communicating crucial safety information to healthcare professionals, patients, and caregivers.
With our expertise, we ensure that your safety communications meet regulatory guidelines and are tailored to be accurate, concise, and user-friendly. Our team focuses on delivering clear instructions and precautions, empowering patients to make informed decisions about their healthcare.
PV System Gap Analysis
Ensure the regulatory compliance and readiness of your Pharmacovigilance (PV) system with our comprehensive on-site PV Gap Analysis service. Our expert team will conduct a thorough evaluation to identify any gaps that require attention, ensuring compliance with regulatory requirements.
You will receive a detailed report outlining the essential components of a compliant PV system and specifying the adjustments needed to achieve regulatory compliance. This report will serve as a roadmap to address identified gaps effectively.
To facilitate the implementation process, we will provide you with an Implementation Plan that outlines a strategic approach to enhance the effectiveness of your PV system. Our goal is to assist you in addressing gaps, achieving regulatory compliance, and establishing an efficient and robust PV system.
Regulatory Intelligence
Our company offers a specialized service in Regulatory Intelligence for Pharmacovigilance, ensuring you stay informed and ahead of the evolving regulatory landscape. With our expertise, we monitor and analyze regulatory changes, guidelines, and requirements relevant to pharmacovigilance, enabling you to proactively adapt your practices and maintain compliance.
Get in touch with us
At Composite Pharma, we believe in building long-term partnerships with our clients and providing exceptional service at every step of the way.
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