Katie Dougherty Email and Phone Number

Pharmobedient Compliance is dedicated to providing clients across the globe an easy and cost-effective solution for complying with the rules and regulations fundamental to doing business in the US market. We apply our years of pharma industry experience to expertly manage FDA-required registrations, certifications and listings. Our FDA Registration services include serving as appointed US Agent, obtaining Labeler codes, creating NDC product listings and handling annual compliance submissions such as Establishment Registration, GDUFA Self Identification, GDUFA Fee payments, NDC product listing certifications and the newly created CARES Act requirement for reporting now due every February. Pharmobedient Consulting provides a full array of regulatory consulting services. We pride ourselves in helping clients successfully resolve complex regulatory challenges. Whether filing an IND/NDA/ANDA/DMF, creating a filing strategy for one of those submissions, preparing for an FDA audit, responding to an FDA audit or simply submitting a Controlled Correspondence — we are here to help in all aspects of your regulatory and product development needs.

Boutique consulting and advisory firm providing strategic, management, and process improvement consulting services to companies including Generics FDF, API manufacturers, branded pharmaceuticals, Biosimilars, patient advocacy groups and trade associations.

Responsible for all US and Canadian activities for Unimark's portfolio of over 35 DMF products manufactured at two FDA inspected facilities in India as well as a newly built, state of the art API and FDF facility for production of Carbapenems.

Responsible for North American API sales following Mylan's acquisition of Matrix Laboratories Ltd.• Directed, drove and maintained sales of APIs to generic pharmaceutical companies in the US from portfolio selection through launch of approved ANDA products• Served as primary sales contact for all API customers in US and Canada • Managed portfolio spanning over 100 API’s from 6 different FDA inspected facilities located in India and coordinated with several other manufacturing and R&D sites on development of new products and site transfers• Negotiated terms of supply contracts and quality agreements • Worked with legal team in India and US attorneys on agreements and intellectual property related topics critical in determining non-infringement for new product offerings as well as at time of launch• Managed staff in areas of Regulatory & Technical Affairs, Customer Service/Imports and Business Development • Responsible for oversight, design, budgeting and planning of operational activities of the US office

Founding team member at ShorePharm LLC, a start-up company focused on sales, marketing, and distribution of APIs manufactured exclusively in India to generic, specialty and branded pharmaceutical companies in the US• ShorePharm achieved sales growth from $0 at day 1 of start-up in July 2002 to greater than $20 million at time of acquisition in May 2006 • Handled Sales, Marketing, Portfolio Selection, Regulatory & Technical Affairs, Project Management, Import and Logistic responsibilities as the company grew in scope and infrastructure• Oversaw all aspects of project management from inception through ANDA approval, launch and commercialization• Researched and identified key branded products coming off patent as well as target alternate source products • Evaluated supply relationships with Indian API manufacturers including extensive travel to manufacturing sites and facilities throughout India• Ultimately, helped establish a portfolio of over 52 DMF products, 55 products in development and 25 new products under evaluation as manufactured by over ten different API manufacturers including Matrix Laboratories, Ipca Laboratories, Jubilant Organosys, Wanbury, Unimark Remedies, Kreative Organics, Suven, SMS Pharmaceuticals, Centaur and Hikal • ShorePharm’s efforts helped Matrix Laboratories, a publicly traded company in India, become one of the fastest growing API manufacturers in India. In May 2006, Matrix acquired ShorePharm as a fully owned US subsidiary. In August 2006, Mylan acquired controlling share of Matrix’ for $736 million.

Responsible for sales and marketing of API to North America based pharmaceuticals companies.• Called on over 30 pharmaceutical companies located in US and Canada and managed business leading to sales greater than $25 million• Responsible for expanding the relationship with each account, maintaining established commercial business, promoting new products and identifying alternate sourcing opportunities with key US generic pharmaceutical customers • Identified new customers, potential new products, and business opportunities• Regularly scheduled in person meetings, attended industry trade shows in the US and Europe and developed presentations for marketing of each manufacturer’s products • Established forecasts, budgets and specific account goals• Sales and technical liaison for corporate computer system development that automated and streamlined the order fulfillment process from receipt of order through customer delivery. Implementation improved order processing times, customer service and internal quality controls • Member of New Product team which identified and evaluated potential new products to add to SST portfolio • Member of committee entrusted with continuous evaluation, improvement and creation of corporate policies and procedures

Assisted foreign manufacturers in developing and maintaining US FDA compliance by:o Submitting Drug Master File (DMF) original submissions, Annual Updates and Amendmentso Reviewing DMF and DMF related filings including process changes and deficiency responses prior to submission to FDA and collaborating with manufacturers and customers to craft FDA responseso Filing and maintaining National Drug Code (NDC) numberso Coordinating audits of European and Indian manufacturers and consulting on audit responseso Keeping abreast of changes in USP monographs, ICH guidances and FDA guidelines and then communicating these changes to manufacturers• Handled customer related Quality Complaints and investigations • Reviewed customer raw material specifications and test methods to ensure compliance of all distributed products • Reviewed and compiled technical packages confirming product met the standards of the USP; and oversaw distribution of samples and technical packages to customers• Handled FDA/Customs on import entries into the US as well as any damage related claims incurred in shipping• Updated and expanded Standard Operating Procedures for Regulatory department to ensure compliance with FDA, DEA and local health authority standards