Veleka focuses her practice on assisting clients with regulatory, compliance and enforcement matters for FDA-regulated products, including food, cosmetics, drugs and medical devices. She represents clients in research, pre-launch, launch, commercialization and licensing activities for first-in-class products and other innovative products. Veleka has served as a legal advisor on various regulatory applications, including New Drug Applications (NDAs) and Biologics License Applications (BLAs) and related supplements, and assisted with preparation for FDA advisory committee and other company-agency interactions. Veleka has also served on committees seeking regulatory authorization for products by Health Canada and the European Medicines Agency (EMA).
She regularly counsels clients on a full range of matters including, marketing authorizations, clinical trials and good clinical practices (GCP); current good manufacturing practices (cGMP), including quality systems and quality management programs; manufacturing and supply chain matters; pharmacovigilance; advertising and promotion; licensing, development and collaboration agreements; compliance and enforcement, including recalls and other field actions, assistance with FDA 483 audits, responses to warning letters, and assistance with corrective and preventative actions (CAPAs) and other FDA enforcement actions. Clients also seek Veleka’s advice and counsel on drug compounding matters under Section 503A and Section 503B of the Federal Food Drug and Cosmetic Act as well as drug supply chain security matters under the Drug Supply Chain Security Act (DSCSA).
In addition, Veleka regularly advises global biopharmaceutical companies in the development and implementation of corporate compliance and ethics programs utilizing her expansive knowledge and experience of the interplay between the PhRMA Code of Interactions with Healthcare Professionals (PhRMA Code), AdvaMed Code of Ethics, Anti-Kickback statute, False Claims Act, and Physician Payments "Sunshine" Act. Veleka has developed and implemented legal and compliance training programs for global pharmaceutical company employees, including medical affairs and sales personnel, healthcare professionals serving as consultants for speaker programs, advisory boards and other consulting relationships, and healthcare professionals serving as clinical trial investigators. Veleka has also conducted audits and investigations on behalf of clients working to ensure adherence to compliance program requirements.
On the corporate acquisition side, she advises biopharmaceutical and private equity companies seeking to invest in or acquire compounding pharmacies, service-providers to the industry, including contract research organizations and contract manufacturing organizations, as well as biopharmaceutical companies and divisions of major pharmaceutical companies.
Veleka developed her extensive industry perspective as former senior in-house legal and compliance counsel for leading biopharmaceutical companies in the private sector and was instrumental in building and managing in-house legal and compliance teams.
Representative Legal Matters
Regularly advise global biopharmaceutical companies on FDA and healthcare compliance related matters in licensing and collaboration agreements and acquisitions
Assisted a global biopharmaceutical client with product recall, field alerts and other related communications with the FDA
Assisted a private equity company in the acquisition of major US product line.
Drafted and negotiated pharmacovigilance agreement for a global biopharmaceutical license, collaboration and co-development agreement
Provided advice and counsel to a global biopharmaceutical company on alliance management programs that involve licensing arrangements with other companies to develop and commercialize products internationally
Assisted global companies with the development and implementation of corporate compliance programs, including various policies and procedures to support the development and commercialization of drugs and combination products
Provided advice and counsel to global biopharmaceutical companies on cGMP, FDA inspection preparation and response, and implementation and execution of corrective and preventative action plans
Assisted global pharmaceutical companies with all pre-launch planning, including the development of a compliance program, clinical trial matters and medical, legal and regulatory review of all company materials
Advised on various FDA regulatory and compliance matters in the merger of a large Japanese pharma and a US biotechnology company
Provided advice and counsel on FDA regulatory due diligence matters to a private equity company in investment in network of compounding pharmacies
- LMG Life Sciences 2020 Regulatory Firm to Watch, Winner
- LMG Life Sciences 2020 Regulatory Attorney of the Year, Finalist
- Who’s Who Legal – Global Healthcare 2020, Recommended
- Most Influential Women in Corporate America, Savoy Magazine 2019
- Life Science Star, LMG Life Sciences 2018 – 2020
- Most Influential Black Lawyers, Savoy Magazine 2018
Professional Associations and Memberships
- American Health Lawyers Association - Member
- Women in Bio - Member
- National Association of Women Lawyers - Member
- District of Columbia~United States (1997)
- South Carolina~United States (1996)
- University of South Carolina (JD) (1996)
- Hampton University (BA, high honors) (1992)
- Core Program Speaker, Graduate Certificate Program in Healthcare Corporate Compliance, The George Washington University College of Professional Studies