CONSULTING SERVICES
Global Regulatory Solutions
Our global regulatory services are designed to help pharmaceutical companies succeed in diverse and challenging markets. We have deep expertise in navigating the regulatory landscapes across America, Europe, Asia-Pacific, Africa, and the Middle East, ensuring that your product meets all local and international requirements. Our tailored services help you mitigate risks, accelerate market access, and ensure continuous compliance.
HOW WE CAN HELP
We’ll ensure that you focus on the opportunities
End-to-end programs.
At PharmAdvis Solutions LLP, our Global Regulatory Solutions provide comprehensive support to ensure your product meets all international requirements, no matter the market. How we can help: We’ll take care of the complex regulatory landscapes so that you can focus on opportunities for growth. From country-specific compliance to post-market surveillance, our end-to-end programs ensure seamless submission, approval, and ongoing compliance across America, Europe, Asia-Pacific, Africa, and the Middle East.
Country-Specific Compliance
Every region has unique regulatory standards. We provide tailored insights into country-specific requirements, ensuring you avoid common compliance pitfalls. Whether it’s the FDA in the U.S., EMA in Europe, or TGA in Australia, our team helps streamline regulatory submissions and accelerate approvals across North America, Latin America, Europe, Asia-Pacific, and Africa & Middle East markets.
Accelerated Market Access
For companies aiming to fast-track product approvals, we offer regulatory strategies tailored for accelerated pathways such as fast-track designation in the U.S., conditional approval in Europe, and priority review in countries like Japan and China. We guide clients through accelerated approval processes, minimizing delays and enabling faster entry into highly regulated markets.
Regulatory Gap Analysis
Our comprehensive regulatory gap analyses identify potential compliance risks before submission. We conduct thorough reviews of your existing processes and documents to recommend corrective actions. This service ensures your submissions meet the latest requirements across regions, including EU regulations, FDA standards, and APAC market guidelines, helping you stay ahead of evolving regulations.
Dossier Preparation & Submission
We specialize in preparing and submitting regulatory dossiers, including CTD/eCTD formats for NDAs, ANDAs, and MAAs. Our team ensures compliance with region-specific requirements in North America, Europe, Asia-Pacific, and Africa & the Middle East, while maintaining high-quality submissions that meet the expectations of regulatory authorities.
Post-Market Surveillance
Our post-market surveillance services ensure ongoing compliance after product approval. We manage pharmacovigilance, risk management plans (RMPs), and periodic safety update reports (PSURs) to ensure product safety in diverse markets. This service covers Europe, North America, Asia-Pacific, and Africa & the Middle East, keeping your product compliant with international safety standards and local reporting obligations.
Regulatory Intelligence and Strategy
We provide real-time regulatory intelligence to keep you informed of changes in global regulations. Our experts monitor evolving guidelines in regions like the U.S., EU, China, Japan, and Africa to help you stay compliant and anticipate future regulatory trends. We develop proactive strategies that align with your global product roadmap, ensuring regulatory success in all target markets.
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Frequently Asked Questions
We provide regulatory services across the globe, including America, Europe, Asia-Pacific, Africa, and the Middle East, ensuring compliance with country-specific requirements.
We offer tailored insights and strategies for meeting the unique regulatory requirements of each country, helping you navigate local regulations and avoid delays..
A regulatory gap analysis identifies potential compliance risks in your product’s regulatory strategy. We recommend corrective actions to help you meet the regulatory standards of different regions efficiently.
Yes, we offer post-market surveillance services, including pharmacovigilance and risk management, to ensure your product remains compliant after it enters the market.
We guide clients through various regulatory pathways such as fast-track approvals, orphan drug designations, biosimilar registrations, and accelerated review processes in different regions.
Our team manages regulatory agency queries and deficiencies, responding effectively to ensure timely approvals and minimize disruptions in the approval process.
Yes, we provide support for the entire product lifecycle, including variations, renewals, and compliance with changing regulations in different markets.
We have successfully managed over 500 regulatory submissions globally, with experience in handling NDAs, ANDAs, BLAs, and MAAs for a wide range of products.
Our regulatory intelligence services provide real-time updates on evolving regulatory landscapes, ensuring that your product remains compliant with new and emerging requirements.
Yes, we establish and manage pharmacovigilance systems for global markets, ensuring your product adheres to local safety reporting requirements and remains compliant post-launch.
Partnering with PharmAdvis Solutions LLP for our global regulatory needs has been a game-changer for Teva Pharmaceutical. Their deep expertise across multiple regions, particularly in the U.S. and Europe, helped us navigate complex regulatory landscapes seamlessly. From dossier submission to post-market surveillance, their proactive and thorough approach ensured full compliance at every stage. The personalized support we received from their team was exceptional, and they consistently delivered results on time. I highly recommend PharmAdvis to any pharmaceutical company looking for expert regulatory guidance
Devina Avina
Global Head
Abbott Pharamceutical Llc