Veleka Peeples-Dyer is an experienced lawyer with an extensive background in the life sciences industry, advising pharmaceutical, biotechnology, technology and medical device companies on Food and Drug Administration (FDA) regulatory and global compliance matters. She counsels global and domestic manufacturers and developers on regulatory and compliance matters throughout the product lifecycle, including clinical trials and current good clinical practices (GCP), product approval and launch, post-marketing, pharmacovigilance, manufacturing, supply, and technical operations-related matters, and current good manufacturing practices (GMP), due diligence, licensing and FDA inspections, compliance and enforcement actions, including 483s and Warning Letters.
Veleka also advises legal and compliance professionals on developing, implementing and enhancing corporate compliance and ethics programs to address a broad range of issues, including advertising and promotion, product safety and adverse event reporting, patient advocacy programs, speaker programs, federal and state transparency and disclosure, including the Federal Physician Payments (“Sunshine”) Act. She has handled significant governmental and internal investigations and designed and implemented both corporate-wide and brand-specific compliance programs and policies. Veleka has advised senior corporate leadership teams on the creation and development of corporate training and compliance programs.
Prior to joining McDermott, Veleka developed an extensive industry perspective as former senior in-house legal and compliance counsel to leading, publicly traded biopharmaceutical companies in the private sector. She has served as a strategic business and legal advisor, counseling on the full range of research, development, regulatory, compliance and commercialization issues facing biotechnology and pharmaceutical companies. Her earlier corporate counsel experience includes working in the government contracts and utilities industries. Drawing on her intimate understanding of industry challenges, Veleka provides strategic and practical counsel to her clients.
Veleka speaks regularly at conferences on legal and compliance issues affecting biopharmaceutical companies.
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
Advised a major global products manufacturer on FDA regulatory strategy for innovative software and hardware solutions for a range of therapeutic and diagnostic applications
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
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
Counseled a private equity companies with FDA and healthcare regulatory due diligence in acquisition of a major contract manufacturer for the biopharmaceutical industry
Provided advice and counsel on FDA regulatory due diligence matters to a private equity company in investment in network of compounding pharmacies
Provided regular legal and compliance advice and counsel to a life sciences support services company