Pharmaceutical Regulatory Consulting Services

According to a study, the global pharmaceutical market is expected to reach USD 3,148 billion by 2034. The projection anticipates the advancement of research and increased scope for innovative treatments to address demanding and rising healthcare needs. On the other side, global health authorities are tightening the Regulatory pathways to ensure that end-users get the right medicine for accurate diagnosis. In this scenario, to deal with a highly regulated industry – pharmaceuticals, manufacturers must understand the regional as well as global Regulatory landscape for accurate dossier preparation, quick healthy authority reviews, approvals, and registrations enabling on-time market entry.

At Vigilare, our priority lies in simplifying challenging regulatory pathways for pharmaceutical manufacturers. With cross-functional expertise and robust domain knowledge, we bring to the table 360-degree pharmaceutical regulatory consulting solutions that span across Pharmacovigilance, and Medical Writing. We aim to bring novel and innovative therapies to market with a strong emphasis on compliance.

Vigilare’s Pharmaceutical Regulatory Consulting Service

Pharmacovigilance (PV)

Drug safety is not optional. It is critical for pharma manufacturers. We at Vigilare ensure that it is followed across the product life cycle. Right from Medical Literature monitoring and MICC activities to submissions of the ICSR cases to the regulatory authorities and from aggregate reporting to signal management, RMPs etc , our expert pharma regulatory consulting team focuses on managing global compliance

Medical Writing

The scientific data is complex. Translating it in a compelling, and compliant way is our forte. Our pharma regulatory consulting team ensure your data is publishing-ready with utmost clarity and accuracy and adhering to Regulatory guidelines irrespective of the type of document you are working on, such as Clinical Study Reports (CSRs), clinical summaries, protocols, and safety narratives.

Pharma Regulatory Consultation & Intelligence

Aiming for smooth market entry without reliable Regulatory intelligence on regional compliance and Regulatory procedural standards is similar to walking the unknown and risking decades of efforts on pharmaceutical innovations. At Vigilare, we assist pharma manufacturers with informed decisions across the product life cycle and assist them with market-entry strategy, publ

publishing and submission procedures, product registrations, and post-approval life cycle maintenance.

Why Partner with Us?

Pharma regulatory consulting experts with vast experience
Proven, flexible, and cost-effective service provision
Customized solutions for small and mid-sized pharma organizations
Global Health-authority-specific compliance expertise – USFDA, EMA, MHRA, CDSCO, etc.

Facts to Focus

Cases Processed

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North American Submissions

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Signal Reports Delivered

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Aggregate Reports

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Testimonials

Partnering with Vigilare for pharmacovigilance services has been a game-changer. Their team is proactive, detail-oriented, and consistently on top of safety updates and regulatory changes across Europe. It’s rare to find such a dependable partner who treats compliance as seriously as we do.

We rely on Vigilare for global pharmacovigilance support across multiple regions. They understand the nuances of each market and consistently deliver accurate, timely, and compliant safety reporting. It’s been a relief having such a competent team on board.

Vigilare’s post-marketing support has helped us maintain compliance seamlessly in the US market. Their responsiveness and structured reporting systems made it easy to keep pace with regulatory expectations. Their clarity and ownership stand out.

We engaged Vigilare during a critical vaccine rollout phase. Their insights into regulatory processes in the Middle East, combined with their ability to coordinate across regions, ensured smooth approvals and timely submissions. They truly acted like an extension of our team.

Vigilare has been instrumental in supporting our medical device registrations in both the US and European markets. From preparing the technical documentation to navigating CE and FDA submissions, their expertise made a complex process feel manageable and well-guided.