After a brief hiatus The Regxia Review is back and focused on bringing to you the most relevant and up-to-date information and resources. From agency guidances and draft guidances, ethical reforms and noteworthy changes in the industry to exciting changes here at home, we are committed to providing you with comprehensive articles on this need-to-know information.
Year in review – 2015
Over 2015 the pharmaceutical industry saw many changes to its regulatory landscape and many more are likely to come in 2016. Locally, one of the most notable events of 2015 for the staff at Regxia Inc. was the successful management acquisition of the company by its co-founders Betty Cory and Lori Steinhoff – de Munnik.
Since co-founding Regxia in 2007, Mrs. Cory (President) and Mrs. de Munnik (Vice President) have built the company to be one of the premier Canadian regulatory consulting firms. Under their leadership and direction Regxia Inc. has earned a reputation of being collaborative and delivering high quality, customized solutions consistent with their client’s company culture and the ever evolving regulatory environment. The desire to provide the client with a one-on-one experience allows Regxia Inc. to work seamlessly with their clients as a trusted partner.
The stability provided by having Regxia’s leadership gain full strategic control of the company has resonated with the staff and clients of Regxia Inc.. The Regxia team is excited for the continued leadership of Mrs. Cory and Mrs. de Munnik and look forward to seeing the company grow under their guidance.
If you are interested in meeting with us in person, Regxia will be exhibiting at a number of leading industry and professional conferences in 2016. In April you can visit us at the ACRP conference in Atlanta (Booth 434), or visit us in Philadelphia at the DIA 52nd Annual Meeting in June (Booth 2042) and for the 9th year in a row we will be attending the RAPS Regulatory Convergence (Booth 211) in San Jose, September 2016.
For those who are new to Regxia, we are a unique scientific and regulatory consulting firm serving the pharmaceutical and biotech industries. Our in-depth knowledge of global regulatory requirements allows us to outline appropriate regulatory strategies which minimize time to market. Our service teams are fully trained and experienced to handle your Regulatory, Clinical & Quality services: Dossier Compilation & Management; eCTD (preparation, management and publishing); CMC; Clinical Monitoring & Management; Pharmacovigilance; SOPs & Reporting; CTAs, INDs, NDSs, and ANDSs are a few of our capabilities.
If you are interested in knowing if Regxia’s collaborative and flexible consulting style is the right fit for your North American and European Regulatory, Clinical or Quality needs, please contact us via our Business Development page on our corporate website, http://regxia.com/contact-us/contact-us.php