Regulatory

At Pharmnova, our Regulatory Services are designed to help you navigate the complex and ever-evolving regulatory landscape with confidence. Leveraging decades of experience and a deep understanding of global requirements, we provide comprehensive regulatory support to ensure your products meet compliance standards while streamlining approval processes.

Our Regulatory Services Include:

Regulatory Strategy and Consultation

Tailored guidance on regulatory pathways, dossier preparation, and compliance strategies to support successful product development and approval.

Regulatory Submissions

Expertise in preparing, reviewing, and submitting regulatory documents, including INDs, NDAs, MAAs, ANDAs, CTAs, and DMFs, to authorities worldwide.

Global Regulatory Intelligence

Continuous monitoring of regulatory changes and updates across regions to ensure your products remain compliant with the latest standards.

Lifecycle Management

Support for post-approval activities, including variations, renewals, and periodic reporting, to maintain product compliance and market presence.

Regulatory Writing and Documentation

Assistance in preparing and updating labeling, package inserts, and patient information leaflets in line with regulatory requirements.

Compliance with Local and International Regulations

Ensuring adherence to guidelines from regulatory bodies such as the FDA, EMA, MHRA, TGA, Health Canada, and others.

Why Choose Pharmnova for Regulatory Activities?

Experienced Team

Regulatory experts with decades of combined experience in the pharmaceutical and biotech industries.

Expertise

In-depth knowledge of regional and global regulatory frameworks.

Customized Solution

Personalized services designed to meet your unique needs and objectives.

Established Process

Proactive solutions to minimize risks and accelerate time to market.

 

Navigating Compliance with Precision and Expertise!

From product development to post-market surveillance, Pharmnova’s regulatory services provide the expertise and support you need to achieve compliance and success in a competitive global market.

Let Pharmnova guide you through the regulatory process with confidence and efficiency.