Consulting Services
Regulatory Solutions
At PharmAdvis Solutions LLP, we provide end-to-end regulatory services that ensure your product’s compliance with global regulatory standards. Our team assists with the development of regulatory strategies tailored to specific regions, guiding clients through the entire regulatory submission process,
from initial filings to post-approval compliance.
how we can help
We’ll ensure that you focus on the opportunities
End-to-end programs.
At PharmAdvis Solutions LLP, we are committed to helping you navigate the complexities of global regulatory requirements with ease. How we can help is by offering tailored, end-to-end programs that ensure compliance at every stage of your product’s lifecycle. From strategic planning to post-approval management, we’ll ensure that you focus on the opportunities ahead while we handle the regulatory challenges. Our comprehensive services, combined with deep industry expertise, streamline the submission process and reduce time-to-market, helping you maximize growth in a competitive landscape.
RegulatoryStrategy
Comprehensive strategies for product registration, including orphan drug designations, fast-track approvals, biosimilar pathways, and accelerated review procedures for innovative products.
Post-Approval Filings
Continuous support with variations, renewals, post-market reporting requirements, and lifecycle management, ensuring ongoing compliance with regulatory authorities.
Dossier Preparation & Submission
Preparation of Common Technical Documents (CTD) and eCTD submissions for NDAs, ANDAs, BLAs, MAAs, and global filings, ensuring accuracy and regulatory compliance.
Pharmacovigilance
Establishment and management of comprehensive pharmacovigilance systems, including signal detection, risk management plans (RMPs), and periodic safety update reports (PSURs) to ensure product safety and regulatory compliance..
Deficiency Handling
Management of regulatory agency queries, deficiencies, and additional information requests (IRs) to ensure timely approvals and minimize delays.
Regulatory Intelligence
Providing real-time insights on changing regulatory landscapes across different countries, helping clients stay ahead of new requirements and market opportunities.
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Client results
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Frequently Asked Questions
We provide end-to-end regulatory services, including regulatory strategy development, dossier preparation and submission, deficiency handling, post-approval filings, and pharmacovigilance.
We tailor regulatory strategies to specific regions, ensuring that your product meets the requirements of regulatory agencies globally, including the USFDA, EMA, TGA, MHRA, and more.
We prepare Common Technical Documents (CTD) and eCTD submissions for NDAs, ANDAs, BLAs, MAAs, ensuring the documents are accurate, compliant, and ready for submission to regulatory authorities.
We develop comprehensive regulatory strategies that include exploring fast-track pathways and applying for orphan drug designations to accelerate approval timelines for qualifying products.
Deficiency handling involves responding to regulatory agencies’ questions or requests for additional information (IRs). We work closely with our clients to resolve deficiencies promptly, ensuring minimal delays in approvals.
Our team provides continuous support after initial approval, managing variations, renewals, post-market reporting, and lifecycle management to ensure ongoing compliance with regulatory authorities.
Pharmacovigilance is the monitoring of drug safety after a product is on the market. We help establish and manage pharmacovigilance systems, including signal detection, risk management plans (RMPs), and periodic safety update reports (PSURs).
We provide real-time insights and updates on changing regulatory landscapes, helping you anticipate and adapt to new requirements in different markets, minimizing the risk of non-compliance.
We provide regulatory solutions for a wide range of products, including pharmaceuticals, biologics, biosimilars, generics, medical devices, and innovative products.
Our team combines decades of experience with global regulatory agencies, a deep understanding of complex markets, and a commitment to providing tailored, end-to-end solutions that focus on both compliance and growth opportunities.
“PharmAdvis Solutions LLP has been an invaluable partner in navigating the complex regulatory landscape. Their expert team guided us through every step of the regulatory submission process with precision and attention to detail. From developing a comprehensive regulatory strategy to managing post-approval filings, they ensured that we met all global compliance standards seamlessly. Their ability to handle deficiency responses and interact with regulatory agencies helped us secure approvals faster than anticipated. The support we received in pharmacovigilance and regulatory intelligence was top-notch, keeping us ahead of evolving regulations. We couldn’t be more satisfied with the quality of their services and highly recommend PharmAdvis to any company looking for regulatory expertise.”
Carol Oliveira,
Head of Regulatory Affairs,Merck Sharp & Dohme