Comprehensive Solutions for Your Regulatory Needs
Gamut Pharma Solutions, we provide cutting-edge regulatory guidance to pharmaceutical, biotech, and healthcare companies. With a team of seasoned professionals, we are dedicated to helping you navigate the complex regulatory landscape with efficiency and precision.
Our Services
Regulatory Strategy & Consulting
Our team designs global regulatory strategies that ensure compliance, reduce development timelines, and facilitate market entry. We conduct gap analysis and product classification assessments to identify potential hurdles and devise solutions.
Global Regulatory Submissions
We specialize in preparing and submitting regulatory documents, including CTD, eCTD, ACTD, and NeeS, across all regions. Our team ensures that all documentation complies with regulatory standards to expedite approval.
Licensing & Certifications
We assist in obtaining necessary global certifications for your products, facilitating licensing in markets worldwide. This ensures that your product can be sold globally in compliance with local regulations.
Regulatory Agency Interaction Support
We support clients in engaging with regulatory authorities, ensuring a smooth and transparent interaction. Our experience allows us to guide you through meetings, submissions, and responses to regulatory agencies.
Analytical Validation & QA
We provide pharmaceutical analytical validation services, ensuring that your products meet rigorous quality standards and regulatory requirements.
Commercial Export & Market Expansion
We guide your product through the complexities of international export and help you navigate different market requirements to expand your reach globally.
Why Us?
Global Expertise
With vast experience in international regulatory affairs, we guide your products through any regulatory environment, ensuring compliance and market access.
Tailored Solutions
We understand that every product and market is unique. Our solutions are customized to your specific needs, timelines, and goals.
End-to-End Support
From regulatory strategy and product development to post-market surveillance, we provide comprehensive support through every stage of your product lifecycle.
Our Address
28-B Basement, Shan Arcade, Barkat Market, New Garden Town, Lahore, Pakistan.