Pharma

A niche IP firm that understands the interplay of Business, Regulatory and Intellectual Property

ANDA strategy and Para IV filing

Competitive Intelligence & Pipeline tracking

Regulatory Support

ANDA strategy and Para IV filing

Legal and Regulatory Expertise: In order to devise an effective ANDA strategy, especially when filing a Paragraph IV, it is imperative to possess a thorough understanding of patent law, FDA regulations, and the drug approval process. Our company provides the necessary expertise and knowledge in these areas to ensure the success of such endeavours
Patent Assessment: Our firm provides comprehensive patent assessment services to generic drug manufacturers, which includes conducting a thorough analysis of the patents listed for the reference product. Our services are designed to help our clients make informed decisions when filing a Paragraph IV certification.
Risk Assessment: Filing a Paragraph IV certification can involve several inherent risks, including the possibility of litigation from the brand-name manufacturer. Our firm is dedicated to minimizing these risks as much as possible, in order to achieve the best possible outcome for our clients. With our extensive experience in this area, we are well-equipped to navigate any challenges that may arise and guide you through this complex process.
Business Considerations: When developing ANDA strategies, it is important to consider not only legal and regulatory factors, but also critical business considerations such as market size, competition, and overall profitability. At our firm, we specialize in providing strategic guidance to help you develop effective ANDA strategies that will ensure your success in the industry.

Pipeline Tracking

Pipeline tracking constitutes a fundamental activity within the pharmaceutical and biotechnology industries. It entails the systematic monitoring of drug candidates throughout different stages of clinical development. Companies gather, analyze, and interpret information concerning competitors, market trends, and industry developments. This practice allows for informed business decisions. Pipeline tracking involves the comprehensive monitoring of products in a company’s pipeline as well as those of its competitors. Linking ongoing clinical trials with corresponding patents represents a valuable strategy, as it can translate into early opportunities.

Regulatory Support

In various fields such as pharmaceuticals, biotechnology, medical devices, and food and beverages, regulatory assistance is of utmost importance to successfully navigate the intricate product development process and obtain regulatory approval. This assistance entails tasks such as preparing Patent Certification letters for regulatory agencies, devising strategies for filing and launching based on the data exclusivity provisions of respective countries, and ensuring that the labeling and specifications submitted to regulatory agencies are aligned with the intellectual property requirements.