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Scientific Support

Because of our regulatory and compliance expertise, we are often asked to provide due diligence for companies considering the acquisition of an asset such as a product, corporate division or an entire company. PharmaTech has two Medical Doctors who are paid consultants, a chemist, a chemical engineer, an exercise physiologist, a pharmacist, and a pharmacologist.

We have experience providing regulatory due diligence for many types of acquisitions, including major corporate pharmaceutical acquisitions. Our resources enable us to instantly mobilize a cross-functional team to work in a virtual data room and meet frequently with the client to advise them during every stage of the process. This hands-on approach helps our clients achieve positive results and we are often asked to stay on to assist with integration as well.

Edmund J. Novotny-Primary Outside Consultant for FTC and Dietary Supplement Law
Ed Novotny provides litigation and counseling services, with a focus in advertising law matters and consumer protection. Edmund Novotny has been listed in Best lawyers in America in 2010, 2011, 2012, and 2013 for Litigation. Edmund Novotny has been named to Georgia Super Lawyers from 2007-2012. Georgia Super Lawyers identifies the top 5 percent of attorneys in each state, as chosen by their peers and through the independent research of Law & Politics. Mr. Novotny is highly respected for offering comprehensive legal advice that emphasizes risk analysis and sound business practices for corporations involved in advertising and marketing. On the regulatory side, clients tell PharmaTech he is “arguably the best advertising lawyer in the US,” and “consistently provides good advice and service.” Ed also focuses his practice on complex business litigation with a particular emphasis on intellectual property and the needs of dietary supplement companies, regulatory compliance, review of contracts, and general business advice. He has extensive experience in state and federal courts handling complex civil litigation, including class actions, in the areas of commercial and consumer litigation, constitutional law and mass torts, employment law, and regulatory disputes. He also has substantial experience with litigation involving religious non-profits, including clerical malpractice and First Amendment issues.

Mr. Novotny is rated AV by Martindale Hubbell (the highest rating possible). Mr. Novotny was Law Clerk to The Honorable Horace T. Ward, U.S. District Court, Northern District of Georgia, 1989-1991 and Instructor, Legal Research, Writing and Advocacy, Emory University School of Law, 1988-1989. Mr. Novotny recently went back out on his own after 7 years being a partner at the International law firm- Baker, Donelson, Bearman, Caldwell & Berkowitz, PC (the 72nd largest law firm in the U.S., Baker who has more than 600 attorneys and public policy advisors representing more than 30 practice areas.

Mr. Novotny has successfully tried 34 case to verdict since he started his career as a litigator. Ed has worked with multiple Pharmaceutical and Dietary Supplement manufacturers over the years, handling all types of the company’s legal affairs, including intellectual property, trademark, trade dress, false advertising, and business litigation, regulatory compliance, and drafting and reviewing contracts. Ed is one of the few lawyers in America with an emphasis on DSHEA compliance and FDA/FTC issues. Mr. Novotny has handled appeals to the 3rd and 11th Circuit Courts of Appeal, all aspects of litigation, discovery, injunctions, and depositions. Mr. Novotny is also well versed in FDA/FTC compliance issues.

PharmaTech Consulting also associates a former Senior member of the U.S. FDA's Dedicated Foreign Drug Inspection Cadre. As a member of the foreign drug cadre, all of his inspections were performed at foreign pharmaceutical manufacturing and testing sites. He performed over 100 foreign pharmaceutical manufacturing site audits in over twenty countries. These FDA inspections experience included six system GMP inspections, Pre-Approval inspections, Post-Approval inspections and For Cause investigations performed at drug substance facilities (API), solid oral & semi-solid dosage facilities, and parenteral manufacturers of both human and animal drug products. He also served as an FDA Compliance Offficer with experience in dietary supplements, drugs, biologics, foods, health fraud and various imported FDA regulated products. His work as a Compliance Officer included reviewing inspection reports & evidence of GMP deficiencies, preparing Warning Letters, preparing seizure documents and legal documents for company injunctions.

PharmaTech Consulting provides pharmaceutical cGMP consulting services to FDA regulated industry. PharmaTech Consulting Consulting specializes in performing mock FDA six system audits of pharmaceutical companies; provides assistance with FDA 483 observations & CAPAs and response letters to FDA; provides Warning Letter response review service, assists during FDA audits in front conference room or in back room during audits, and provides various other GMP consulting services.

PharmaTech has two Medical Doctors who are paid consultants, a chemist, a chemical engineer, an exercise physiologist, a pharmacist, and a pharmacologist. These experts not only can help in crafting advertisements and gather substantiation to ensure that any ad your company disseminates is backed by the FTC “competent and reliable scientific standard.” If litigation were to be necessary these experts can testify to help defend any case involving pharmaceuticals or dietary supplements. Lastly, they can help the lawyers with new drug (IND, NDA) and generic drug (ANDA) applications.

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