Providing Strategic Regulatory Guidance/Advice to Pharmaceutical
and Biotech Companies Via Online
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About Us

Pharmaceutical regulatory Affairs is a truly specialized field and one that makes finding trustworthy help difficult. GRSAOnline works with companies all over the world, allowing us to be readily available for all companies seeking our services. Give us a call or send us an email for an efficient response to your regulatory question or issue.

GRSAOnline Strategic Team

Dave Loew - Chief Executive Officer

Dave joined GRSAOnline as CEO as of January 2013. A recent and on-going skilled pharmaceutical industry executive. His background includes over 20 years of pharmaceutical R&D, sales and regulatory affairs experience, while holding positions at well-known major global pharmaceutical companies as well as smaller companies focused on the development of novel therapeutics. Previously Dave served as a regulatory consultant for Shire Pharmaceuticals. He was responsible for the preparation of INDs, NDAs and other submissions to regulatory agencies, was delegated to project team liaison tasks, and offered regulatory support to preclinical, clinical, manufacturing, quality assurance and marketing departments when needed. Prior to Shire, Loew worked on a vast array of regulatory projects at other companies such as Wyeth, Johnson & Johnson, Bristol-Myers Squibb, GlaxoSmithKline and Sanofi.

Dave received his Bachelor’s of Science in Biology from Bucknell University in Pennsylvania and began his career in R&D and sales before transitioning his pharmaceutical ambitions into regulatory affairs. 

 Dr. Farshad Shaban - Chief Scientific Officer 

Farshad Shaban, Ph.D serves as the chief scientific officer and is a member of the board of directors of GRSAOnline. Dr. Shaban has a proven track record in biotechnology and pharmaceutical industry in the areas of biopharmecutics/analytical development with experience in bio-Assays conducting pharmacokinetics and pharmacodynamics studies in support of PI, PII, PIII, and post marketing (Phase IV) clinical trials and statistical analysis of the data. His background includes over 20 years of pharmaceutical R&D, pre-clinical development, biopharmaceutics, statistics including quality systems, quality assurance, compliance, regulatory, analytical/bioanalytical method development and validation, quality audits, and project management. His experience includes positions held at large and small pharmaceutical/biotech companies including; Hoffman La Roche, Skypharma, and Validation Laboratories and as a consultant at Novartis in Nebraska, and J&J in PA.

Farshad received his PhD in Analytical Chemistry from Villanova University in Pennsylvania.

Narayan Rao - Director-Chief Regulatory Advisor

Narayan was recently employed at Chugai Pharma USA (a subsidiary of Hoffman La Roche) and held the position of US-Head of Regulatory Affairs. His background includes over 20 years of pharmaceutical R&D, global regulatory affairs experience, while holding positions at well-known major global pharmaceutical companies as well as smaller companies focused on the development of novel and established drugs in several therapeutic areas including oncology, inflammatory/pain, immunology, antiviral and therapeutic cancer vaccines. He was responsible as a primary global regulatory member in several major pharmaceutical companies in the development  and implementation  of regulatory strategies for early and  late stage development of new drugs and biologics in various therapeutic areas including but not limited to oncology, rheumatology, endocrinology, hematology, and dermatology. He also served as the primary liaison with regulatory authorities and managed the strategy and execution of these interactions.  During 1998-2003, Narayan was an adjunct professor at Temple School of Pharmacy, RA/QA graduate program, teaching global regulatory course for industry and non-industry professionals. Narayan has Bachelors in Chemsitry from Madras University, and MBA from Temple University's Fox School of Business.

BOARD OF DIRECTORS

Dave Loew - CEO

Dr. Farshad Shaban - Chief Scientific Officer 

Narayan Rao - Director-Chief Regulatory Advisor

Don't Become a Statistic
Our staff's more than 40 years of combined experience and commitment to providing positive, realistic and results-oriented strategic regulatory advice enabling you to reach your milestone/goal in the field of pharmaceuticals or Biopharmaceuticals. Recent statistics show that 90% of all biotech companies end in failure. Given that the pharmaceutical industry is heavily regulated, GRSAOnline enables your company to navigate and simplify various regulatory challenges to achieve success.

 

Contact GRSAOnline for sound advice on the development of your drugs.

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NOTE - We will promptly inform you if GRSAOnline is unable to service your request/assignment.

LIABILITY OF GRSAOnline - In furnishing any Client/Company or individual with the Regulatory Advice Consulting Services, GRSAOnline shall not be liable to any Client/Company/Individuals or its creditors for errors of judgment or for any matters, except for willful malfeasance, or gross negligence in the performance of the Services.  It is further agreed and understood that GRSAOnline may rely upon information furnished to it by Client/Company/individual which GRSAOnline reasonably believes to be accurate and reliable and that GRSAOnline shall not be accountable for any loss suffered by Client/Company/individual by the reason of Client's/Company's/Individual's action or non-action on the basis of any advice, recommendation or approval of GRSAOnline, its employees, officers, directors or agents, except as provided above.