Has 34 years of experience in the Biopharmaceutical industry. President and the Principal consultant of PCH Integrated Regulatory and Compliance Services, Inc. in California, USA and Montreal, Canada. Services include proactive and strategic regulatory planning,submission, GXP auditing and development supports to emerging and start-up biopharmaceutical companies worldwide. Recognized regulatory expert in 505b2 applications, eCTD submissions and has extensive experience in GCP/GMP auditing in Eastern Europe and Asia. Before founding PCH in August 1998, was the Vice President, Worldwide Regulatory Affairs, Quality Assurance and Drug Safety at Sepracor Pharmaceutical Inc., responsible for the implementation of a science-based regulatory strategy to expedite the development of single isomers/active metabolites of marketed drugs, new chemical entities and combination products. Held various hands-on and management positions in Regulatory Affairs, Regulatory Operations, Quality Assurance, Post-marketing Surveillance, Project Management and CNS Research at Sepracor, Occulon,AstraZeneca, Aventis and Wyeth, respectively. Well recognized for in-depth knowledge and hands-on experience of utilizing the 505(b)(2) NDA provision to develop unconventional pharmaceutical products, including combination products and follow-on proteins (biosimilars/biogenerics). Has affiliates in E. Europe and Asia, specialize GCP audit of complex clinical studies. Services include: • Advise on US, Canadian and European registration requirements • Prepare and assess regulatory strategy and technical dossiers • Plan, rehearse and attend regulatory authorities and Ad Com meetings • Act as liaison and official correspondent for FDA and HPFB in Canada • Advise on nonclinical , clinical and CMC IND/NDA requirements • Provide GXP auditing, customized support in due diligence audit and regulatory intelligence tracking

President and Principal Consultant @ Provide regulatory advice and development support to pharmaceutical companies; implement regulatory strategy to expedite product approval; deploy risk management and quality compliance program to meet regulatory requirement for drug, device, drug/device combination products and biosimilars. From August 1998 to Present (17 years 5 months) Regulatory and Compliance Consultant @ Provide operational and strategic support in regulatory (pre-IND to NDA development) and quality compliance. Act as company official regulatory contact. From January 2009 to Present (7 years) Greater New York City AreaScholar Consultant @ Provide regulatory advice, assess product approval risk and evaluate investment opportunities for financial institutions. From January 2002 to Present (14 years) Regulatory Advisor @ From February 2010 to Present (5 years 11 months) Expert Healthcare Industry Advisor @ From January 2010 to Present (6 years) Regulatory and Compliance Consultant @ From April 2004 to Present (11 years 9 months) Regulatory Affairs Consultant @ From April 2011 to Present (4 years 9 months) Raleigh-Durham, North Carolina AreaRegulatory Advisor @ From December 1998 to Present (17 years 1 month) Regulatory Affairs Consultant @ From February 2010 to May 2015 (5 years 4 months) Austin, Texas AreaRegulatory Consultant @ From January 2008 to January 2014 (6 years 1 month) Regulatory Consultant @ From July 2008 to April 2013 (4 years 10 months) Technical Regulatory Advisor @ From February 2008 to January 2013 (5 years) Regulatory Advisor @ From January 2004 to December 2012 (9 years) Regulatory Consultant and Acting Project Manager @ From January 2009 to November 2012 (3 years 11 months) Regulatory Consultant @ From January 2008 to December 2011 (4 years) Regulatory Consultant @ From February 2007 to December 2011 (4 years 11 months) Greater San Diego AreaRegulatory Consultant @ From 1999 to 2011 (12 years) Irvine California @ From February 2007 to November 2010 (3 years 10 months) Regulatory Advisor @ From 2006 to 2010 (4 years) Regulatory Consultant @ From 1999 to 2009 (10 years) Regulatory Advisor @ From 2002 to 2005 (3 years) Vice President Worldwide Regulatory Affairs and QA @ From 1994 to 1998 (4 years) Associate Director of Regulatory Affairs @ From 1992 to 1994 (2 years) Manager, Regulatory Affairs @ From 1988 to 1992 (4 years)

Pauliana Hall is skilled in: Oncology, Endocrinology, Dermatology, Infection, Urology, GI, Ophthalmology, Pharmaceutical Industry, Research, GCP, Start-ups, Clinical Trials, Pharmacovigilance, FDA, Biopharmaceuticals