Veleka Peeples Dyer

Veleka Peeples-Dyer

Partner
Baker & McKenzie LLP

Biography

Veleka Peeples-Dyer is Chair, North America FDA Practice Group for Baker McKenzie. Veleka brings more than 20 years of strategic and practical business and legal counsel to a wide span of biopharmaceutical companies, advising on FDA regulatory and compliance matters, including over 15 years of senior in-house counsel experience in leading biopharmaceutical companies.

Practice Focus

Veleka’s practice provides full coverage for clients, including, but not limited to, clinical trials and good clinical practices (GCP); current good manufacturing practices (cGMP), including quality systems and quality management programs; pharmacovigilance; advertising and promotion; licensing, development and collaboration agreements; and compounding and compliance and enforcement, including assistance with FDA 483 audits, responses to warning letters and assistance with corrective and preventative actions (CAPAs) and other FDA enforcement actions. In addition, Veleka regularly works with global biopharmaceutical companies, assisting in the development and implementation of corporate compliance and ethics programs. She also 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, biopharmaceutical companies and divisions of major pharmaceutical companies.

Representative Legal Matters

Prior to joining the Firm, Veleka handled the following matters:

  • 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.

  • Counseled a private equity companies with FDA and healthcare regulatory due diligence in acquisition of a major contract manufacturer for the biopharmaceutical industry.

  • Provided regular legal and compliance advice and counsel to a life sciences support services company.

  • Advised global pharmaceutical company on acquisition of pharmaceutical products into existing company portfolio.

Professional Honors

  • “Most Influential Women in Corporate America,” Savoy Magazine 2019
  • Life Science Star, LMG Life Sciences 2019
  • “Most Influential Black Lawyers,” Savoy Magazine 2018
  • Life Science Star, LMG Life Sciences, 2018

Professional Associations and Memberships

  • American Health Lawyers Association - Member
  • Women in Bio - Member
  • National Association of Women Lawyers - Member

Admissions

  • District of Columbia~United States (1997)
  • South Carolina~United States (1996)

Education

  • University of South Carolina (JD) (1996)
  • Hampton University (BA high honors) (1992)

Languages

  • English