ANNA PAVLOU advises life sciences and healthcare companies on a broad range of EU regulatory and compliance issues. Her practice focuses on regulatory counseling and compliance matters on all aspects of EU regulatory and healthcare law that impact pharmaceutical, biotechnology, medical device and in-vitro diagnostic manufacturers; food business operators; cosmetic products and consumer goods manufacturers and distributors; digital health companies; and private equity firms focused on life sciences and healthcare.
In particular, Anna manages key strategic matters for corporate clients and trade associations on a broad range of market access and life-cycle management issues such as clinical trials, good manufacturing practice (GMP) compliance, vigilance (including pharmacovigilance/drug safety), marketing authorization and certification procedures, labeling, advertising and promotional issues, supply chain management, drug shortages and recalls, as well as general product safety and product recall procedures. She has represented clients in matters before the European Commission, the European Medicines Agency, the European Food Safety Authority and numerous Member State authorities.
She has significant experience developing, implementing and assessing corporate regulatory compliance programs including drafting policies and procedures, advising on implementation matters, counseling on complex regulatory inspection issues, and conducting audits, pre-inspection preparedness visits and internal regulatory reviews. She also advises on EU regulatory contractual issues, including distribution, warehousing, logistic services, supply, manufacturing, quality, pharmacovigilance, as well as R&D and other collaboration agreements.
Anna also regularly leads EU regulatory due diligences for private equity firms and life sciences clients. She works closely with Sidley’s Private Equity, M&A and Technology and IP Transactions groups to provide clients with integrated and pragmatic regulatory advice, making strategic recommendations on areas of potential risk.
Her recent experience on transactional matters includes, regulatory advice for:
- GHO Capital Partners LLP on its acquisition of Ardena.
- Multiple transactions by RoundTable Healthcare Partners and their portfolio companies, including the acquisitions of Moberg Pharma’s OTC business (d/b/a Advantice Health), Beaver-Visitec International and Tidi Products, the investment in Deerland Enzymes and Probiotics, add-on acquisitions for Argon Medical Devices (including the acquisition of Angiotech Pharmaceutical’s biopsy/interventional business), Tidi Products’ acquisition of Posey, Aspen Surgical Products, Beaver-Visitec International, CorePharma and Vesta.
- RTI Surgical Holdings, Inc. in connection with the sale of the company’s OEM business to Montagu Private Equity, a leading European private equity firm.
In 2014, Anna co-founded the Women’s Life Sciences Network (WLSN), an international networking group established for female life sciences regulatory professionals.
Prior to entering private practice, Anna gained six years of regulatory and legal experience in the above issues at the European Parliament and the European Commission. During a three-year term in the European Commission’s Directorate-General for Health and Consumers, she was responsible for developing policy and managing legislation in the area of Public Health, and in particular substances of human origin (blood, tissues and cells and organs) and advanced therapy medicinal products (ATMPs).
In Chambers Europe 2020, clients describe Anna as a “very good, dynamic lawyer.” In the previous 2019 edition, sources state that Anna is “very client-oriented” and offers “very deep knowledge of the consumer goods industry.” The 2018 edition notes that she is “very efficient and managed the case and different parties well.” In addition, Anna featured in Chambers Europe 2017 with clients commenting that she has “great technical and subject matter expertise,” and provides “fantastic client support and [is] extremely practical in the issues presented to her.” Anna also features among the “Rising Stars – Life Sciences” of Legal Media Group’s Expert Guides 2019.