Welcome to our Web site
It is my hope that you will find the site informative and useful. It is my goal to
provide the highest quality legal and counseling services to you and your
business. I welcome the opportunity to talk with you and to discuss your legal and
regulatory needs as they pertain to the Food and Drug Administration.
Our office is located at 60 State Street, Boston, Massachusetts. We can be
contacted via telephone at (617) 878-2089 or through the contact page of this site.
The Olsen Group want’s to thank all of our clients who have made this an
exciting and rewarding year. To better serve our clients, we take great
pleasure in announcing the opening of our Washington, D.C. Office in
early 2008.
It is my hope that you will find the site informative and useful. It is my goal to
provide the highest quality legal and counseling services to you and your
business. I welcome the opportunity to talk with you and to discuss your legal and
regulatory needs as they pertain to the Food and Drug Administration.
Our office is located at 60 State Street, Boston, Massachusetts. We can be
contacted via telephone at (617) 878-2089 or through the contact page of this site.
The Olsen Group want’s to thank all of our clients who have made this an
exciting and rewarding year. To better serve our clients, we take great
pleasure in announcing the opening of our Washington, D.C. Office in
early 2008.
Food and Drug Law
The Olsen Group's Food & Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food, Drug, and Cosmetic Act. The Food & Drug Practice
represents manufacturers and distributors of food, dietary supplement,
pharmaceutical, medical device, personal care and cosmetic products, and
products of biotechnology,as well as individuals and institutions involved in clinical
research of FDA-regulated products.
In addition to extensive experience in the corporate, and regulatory aspects of
food, drug and device law, The Olsen Group can offer a broad range of scientific
and technical knowledge that allows us to provide assistance in all stages of a
products life cycle, including: development, approval, marketing, enforcement and
ongoing compliance.
The Olsen Group's Food & Drug Practice offers comprehensive legal and
regulatory counseling to companies and other organizations regulated by FDA
under the Federal Food, Drug, and Cosmetic Act. The Food & Drug Practice
represents manufacturers and distributors of food, dietary supplement,
pharmaceutical, medical device, personal care and cosmetic products, and
products of biotechnology,as well as individuals and institutions involved in clinical
research of FDA-regulated products.
In addition to extensive experience in the corporate, and regulatory aspects of
food, drug and device law, The Olsen Group can offer a broad range of scientific
and technical knowledge that allows us to provide assistance in all stages of a
products life cycle, including: development, approval, marketing, enforcement and
ongoing compliance.
Privileged and Confidential audits and reviews of critical and sensitive
operations including CAPA system audits, Fraud audits, GMP audits
and Pharmacovigilance audits to ensure compliance with design
specifications as well as FDA requirements.
operations including CAPA system audits, Fraud audits, GMP audits
and Pharmacovigilance audits to ensure compliance with design
specifications as well as FDA requirements.
Quality Systems and Regulatory Compliance
As part of the services we provide our customers, The Olsen Group provides a
full range of quality systems consulting services. By leveraging quality systems
and quality management, companies can maximize and achieve break through
business performance while maintaining exceptional regulatory compliance. It is
our philosophy that quality systems must be integrated with business systems
thus providing management with an integrated operating network. We have the
ability to develop unique and customized quality systems for your particular need
thus helping your businesses maximize productivity and efficiency.
We also help clients understand their current compliance position and develop
plans to unleash the hidden efficiency of their business. It is our belief that
regulatory solutions need to meet the business needs of our clients. We believe
that our solutions-focused business approach to regulatory compliance reflects
our unique combination of regulatory expertise and practical industry experience.
As part of the services we provide our customers, The Olsen Group provides a
full range of quality systems consulting services. By leveraging quality systems
and quality management, companies can maximize and achieve break through
business performance while maintaining exceptional regulatory compliance. It is
our philosophy that quality systems must be integrated with business systems
thus providing management with an integrated operating network. We have the
ability to develop unique and customized quality systems for your particular need
thus helping your businesses maximize productivity and efficiency.
We also help clients understand their current compliance position and develop
plans to unleash the hidden efficiency of their business. It is our belief that
regulatory solutions need to meet the business needs of our clients. We believe
that our solutions-focused business approach to regulatory compliance reflects
our unique combination of regulatory expertise and practical industry experience.
| ADVERTISING David M. Olsen, P.C. This web site represents “advertising” on the part of the law firm. It is designed to provide general information for clients and friends of the firm and should not be construed as legal advice, or legal opinion on any specific facts or circumstances. The information presented at this site is general information only and should not be construed as formal legal advice or the formation of a lawyer/client relationship. |
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| A Professional Corporation Specializing in Food and Drug Law Compliance Consulting Litigation |