Navigating You Through the FDA Regulatory Process
Biotechnology & FDA Compliance Counsel
Top Rated Nationwide Biotechnology Law Team
With a healthcare and life science background, TALG represents publicly traded and smaller market Biologics and Biotech firms, from coast to coast. TALG merges law with science to counsel clients in a wide array of biotech areas including FDA compliance issues, capital markets, corporate governance, and product development issues. Proud to call itself an “academic” law firm, TALG attorneys are skilled professionals with science backgrounds in Genetics & Genomics, Biotechnology, Enterprise & Entrepreneurship. With over 15 years of dedicated and exceptional service to our clients, our team possesses the know-how and is prepared to assist you with all of your biotech legal needs. We look forward to providing you with quality, effective, and thorough representation.
Work With Us
Biotechnology Practice Areas
FDA Regulatory Issues
Good Manufacturing Practices (GMP)
Company Governance Issues
Biotechnology Capital Markets
Having access to capital markets is critical, and we leverage our experience in credit transactions, private equity and equity offerings to the advantage of our clients.
Biotechnology governance and regulatory issues
At the production and distribution level – We understand the need for current Good Manufacturing Processes (cGMP) compliance under the relevant Codes of Federal Regulation (CFR).
We have experience counseling clients with product recall issues and adverse event and problem reports (MDR) as required by the CFR(s).
FDA compliance and registration
We’ve counseled our clients with respect to Biologics License Applications (BLA) and premarket submissions. Moreover, we’ve counseled our clients in biosimilar and interchangeable products through abbreviated license applications as set forth in the Biologics Price Competition and Innovation Act of 2009.
We’ve assisted clients with Investigational New Drug Applications (INDs) for CBER regulated products. Moreover, we’ve assisted companies with New Drug Applications (NDAs) as promulgated under 21 CFR 314.
We’ve assisted our clients with 510(k) premarket notification submissions and Premarket Approvals (PMA) for Class I, II and III devices. Moreover, we have experience counseling clients with respect to Investigational Device Exemption (IDE) for clinical studies and Medical Device Reporting (MDR).
We understand the Biotech Industry
TALG Law is dedicated to pursuing our clients’ best interests. Whether it be working with them through company governance issues or obtaining regulatory approvals, we pride ourselves in providing zealous, thorough, and efficient advocacy from start to finish.
As zealous advocates, we use our arsenal of legal knowledge, combined with strategic thinking and planning, to achieve results.
Our work is both thorough and thoroughly communicated. We recognize that each case is different and deserves quality preparation. Additionally, we keep clients well apprised, so they know what is happening with their case, what our strategies are, and what to expect during each step of the process.
We recognize that there is not a one-size-fits-all approach to biotech law. Our team understands the science behind our clients’ products, processes and properties. We understand emerging and established technologies pertaining to biotechnology industries.
Our results speak for themselves, and our reward for those results are lifelong relationships with our clients.
Ismail Amin, Esq.
Ismail is a multi-jurisdictional practitioner with substantial experience in business, intellectual property transactions and disputes. Ismail has handled disputes all over the world and throughout the United States on behalf of Fortune 500 companies and mid-sized privately held companies in fields such as healthcare, biologics, biotechnology and hospitality. In the Board Room – Ismail has counseled the firm’s healthcare provider clients in acquiring or selling assets, while maximizing return and minimizing risk. He has helped clients acquire or sell over $1 billion worth of healthcare-related assets, including hospitals.
Ismail has considerable trial and arbitration experience, having been involved in over 80 trials and arbitrations across multiple jurisdictions from the inception of his legal career. He has successfully litigated shareholder accounting disputes, trade-secret matters, trademark/trade-dress infringement claims, commercial and breach of contract matters, complex commercial litigation. Ismail has substantial experience before the USPTO, having litigated multiple TTAB proceedings involving trademark disputes.
Currently attending – Johns Hopkins University Advanced Academic Programs – Master’s Degree Program – Biotechnology, Enterprise and Entrepreneurship
Graduate Certificate from Stanford Medicine – Genetics & Genomics (2019)
Scientific Experience (Legal):
Representation of Global and publicly traded Biologics company which utilizes human plasma to manufacture therapeutics which treat various diseases; Representation of smaller privately held biotechnology companies in connection with FDA approval issues and financial compliance issues; Representation of medical providers (hospitals) in connection with FDA and CMS compliance issues.
Dima Hanna joined the TALG Irvine office in 2021. Dima was born and raised in Dubai, United Arab Emirates and moved to California to attend Chapman University, where she graduated cum laude with her Bachelor of Science in Business Administration with an International Business emphasis and minor in Sociology. Dima thereafter graduated from Southwestern Law School, where she received her Juris Doctorate with a concentration in Civil Litigation and Advocacy.
During her time at Southwestern, Dima gained diverse experience while clerking for the Los Angeles District Attorney’s family violence unit, along with time spent in firms specializing in criminal defense, personal injury, and family law – where her passion for family law was solidified. Dima was also a member of the Entertainment Law Society and a quarter-finalist in the Negotiations Honors Competition. At TALG, Dima’s main focus is family law as well as business transactional law.
Dima volunteers for the Lebanon Relief Center during her visits home, and continues to contribute her efforts to a Vietnamese orphanage, for which she participated in a month-long Service Trip to Vietnam. In addition to this, she has traveled to 20 countries and continually enjoys exploring new cultures. Dima is bilingual in Arabic and English and also spends her free time boxing, skiing, and attending live music events.