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.