Accelerate your regulatory approval with AI & RWD-driven expert guidance

At Synapmed, our regulatory services are powered by a unique blend of advanced generative AI and data analytics technology and a highly skilled regulatory affairs team, ensuring a seamless path to approval. Our experts provide precise regulatory monitoring and interpretation of changes in regulations, while our cutting-edge intelligent automation workflow tools streamline submission processes and strategy development. Together, our technology and talent drive faster, more confident compliance.

why synapmed?

At Synapmed, we blend a deep bench in regulatory affairs with the latest augmented intelligence technologies to streamline your regulatory journey. From customized regulatory monitoring and strategic planning to efficient submissions and post-approval support, our dedicated team ensures compliance and optimizes your product’s market readiness. We proactively address your regulatory challenges with precision so you can focus on bringing safe, effective products to market.

Services

RWD Analytics

Leverage real world data to support regulatory submissions, supplementing clinical and lab data to demonstrate safety, efficacy, and long-term outcomes for new therapies.

RWD/Data Analytics Team Staffing

Integrate data science specialists with your regulatory affairs team to streamline and optimize submission processes.

Regulatory Intelligence

Stay ahead with our tailored regulatory monitoring and expert analysis. Using advanced technology, we deliver secure, efficient insights and timely compliance so you can focus on bringing safe, effective products to market.

Regulatory Submission & Post-Submission Support

Ensure seamless regulatory submissions, including investigational new drug applications (INDs), new drug applications (NDAs), and marketing authorization applications (MAAs), with our expert writing, review, and compliance services. Post-approval, we maintain compliance through ongoing monitoring, reporting, and post-market surveillance.

Medical Affairs

Collaborate with global regulatory teams for consistent and compliant submissions across regions and countries. Our Medical Affairs expertise ensures documentation is up-to-date and regulatory requirements are met.

Pharmacovigilance & Safety

Improve product safety and regulatory compliance across the entire product lifecycle with our expert pharmacovigilance services delivery team.

Technology IMPLEMENTATIONS

Fuel your initiatives with our cutting-edge technology services, driving innovation and operational excellence.

Solve regulatory challenges with specialized, automated intelligence and data analysis-driven solutions

Our expertise in RWD, supported by intelligent automation processes, can help you overcome regulatory hurdles at every stage of product approval. These use case examples showcase our ability to turn complex challenges into actionable solutions, ensuring a smoother path to market.

outsourcing

What is the Right Outsourcing Strategy for Your Company? Not One Model Fits All

Pharmacovigilance (PV) is crucial for the pharmaceutical and biotech industries as safety regulations grow increasingly complex. Companies encounter challenges in managing rising data volumes, resulting in higher costs and a need for specialized expertise. In response, many organizations are outsourcing PV functions to cut costs and tap into expert knowledge. Successful outsourcing hinges on careful partner selection aligned with specific needs, while retaining essential tasks in-housed when necessary. By effectively managing these partnerships, companies can navigate the complexities of pharmacovigilance while concentrating on their core competencies.

Dedicated to youR Project

No matter the size or scope of your projects, you have a committed partnership team with Synapmed. A team that listens, pays attention to details, and brings smart insights to the table. All so you can solve real problems throughout the product development and commercialization lifecycle.