We assists MAHs in maintaining the PV System Master File and preparing or managing RMPs to ensure product benefit outweighs risk.
We supports diverse post-marketing pharmacovigilance needs and requirements, and implements robust signal detection programs.
Clinical program initial stages can be costly, but our scalable model offers a safety database, expert project teams, and regulatory intelligence, with flexible expansion and pricing.
We offers cost-effective worldwide scientific literature review services, including robust search strategies to ensure continuous surveillance and compliance.
We offers signal detection across all product lifecycle phases, leveraging robust knowledge, diverse data sources to ensure compliance and patient safety.
We ensures accurate, timely submissions to authorities, maintaining over 99% compliance through our proprietary global Safety Regulatory Intelligence.
Our expert team supports the preparation of RMPs or REMS to ensure product benefits outweigh risks, and prepares PSURs/PBRERs and DSURs.
We prioritizes compliance, boasting over 99% success in submitting of monthly ICSRs to health authorities and partners, achieved by proprietary global Safety Regulatory Intelligence tool.
When selecting a Pharmacovigilance (PV) provider, prioritize quality, efficiency, and compliance as fundamental criteria. Beyond these basics, evaluate a provider's capacity to address your unique needs and unexpected requests, including their flexibility in handling unusual projects.
A crucial step involves assessing the cultural fit for a long-term partnership, ensuring mutual understanding. Ultimately, a truly successful PV partnership is revealed by how the provider operates autonomously, anticipating needs and proactively enhancing your project, including readiness for expedited submissions, proactive sharing of efficiency improvements, and awareness of impending regulatory changes.
We invite you to challenge us with your questions, and let AceBiologic demonstrate our commitment to treating every client's project with singular focus.
Enhance and manage your product's safety effectively and confidently meet your regulatory obligations.
Navigating the complex regulatory landscape for new and existing products demands proven methodologies, extensive knowledge, and specialized technical expertise. A trusted partner who can offer guidance on meeting FDA mandates, ensuring a drug or biologic product's benefits outweigh its risks, is invaluable.
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AceBiologic, a leader in pharmacovigilance, integrates extensive clinical expertise with cutting-edge technologies. This enables biopharmaceutical companies to meet global and local pharmacovigilance regulations throughout the entire product lifecycle, from early clinical development to post-marketing surveillance.
Our team of pharmacovigilance experts deeply understands the complex and rapidly evolving safety landscape and its regulations. We're supported by an unparalleled technology suite and committed to the principle that patient safety is a critical industry responsibility.
Pharmacovigilance is vital for drug development and establishing a product's benefit-risk profile, making the selection of the right partner critical for success. AceBiologic empowers our clients to identify and manage potential risks associated with their products, uphold patient safety, and ensure high regulatory compliance throughout the entire drug development and commercialization process.
Our specialists are ready to work on your next awesome project
Contact us today to get started!
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Email: business@acebiologic.com
Phone: +55 (111) 123 777
