OUR COMPANY

RegSource Consulting was founded in 2008 as a company dedicated to providing product development and regulatory services to the Pharmaceutical, Biotechnology, Generics and Medical Device industries.

The aim of the company was to establish a different approach to providing product development consulting, one that approached each issue not only from a Product Development and Regulatory perspective, but also from an overall company product/process based perspective.

SPACEFILLER

OUR COMPANY

RegSource Consulting was founded in 2008 as a company dedicated to providing product development and regulatory services to the Pharmaceutical, Biotechnology, Generics and Medical Device industries.

The aim of the company was to establish a different approach to providing product development consulting, one that approached each issue not only from a Product Development and Regulatory perspective, but also from an overall company product/process based perspective.

SPACEFILLER

OUR COMPANY

RegSource Consulting was founded in 2008 as a company dedicated to providing product development and regulatory services to the Pharmaceutical, Biotechnology, Generics and Medical Device industries.

The aim of the company was to establish a different approach to providing product development consulting, one that approached each issue not only from a Product Development and Regulatory perspective, but also from an overall company product/process based perspective.

SPACEFILLER

ENTREPRENEURSHIP

TEAMWORK & COLLABORATION

PROFESSIONALISM

Our Core Values

RESPECT

EXCELLENCE

INTEGRITY

THE WAY WE WORK

Our major objective is ensuring success for our clients. We achieve this by creating teams of key strategists and subject matter experts, problem solvers and staff, who are recognized for their abilities to achieve results.

OUR CULTURE

We value the contributions of each employee and believe success is derived from having teams that reflect a varied and diverse background with new ideas and new perspectives.

OUR EXPERTISE

Our senior consultants have significant experience in successfully taking billion dollar revenue products to market, and working with some of the top ten Biotechnology and Pharmaceutical companies. We have leveraged this experience in helping smaller companies prepare for commercialization of their products and help them further accelerate their regulatory submission time to market.

OUR BELIEFS

We believe in always being professional and achieving results for our clients by:

– Delivering high quality work output on time and providing valuable thought leadership.

– Being dedicated to developing and helping one another and our clients. Our organization is for leaders who want the freedom to do what they think is right.

– Regarding individuals for their competence and leadership, not on their title alone

OUR COMMITMENTS

To assess and leverage the internal and external culture of each organization whilst providing industry and real-world experience.

To build long term relationships with our clients and add value and productivity to each organization we work with.

To do it right the first time by providing the most knowledgeable and well equipped teams for each assignment.

OUR EXPERTISE

Our senior consultants have significant experience in successfully taking billion dollar revenue products to market, and working with some of the top ten Biotechnology and Pharmaceutical companies. We have leveraged this experience in helping smaller companies prepare for commercialization of their products and help them further accelerate their regulatory submission time to market.

OUR BELIEFS

We believe in always being professional and achieving results for our clients by:

– Delivering high quality work output on time and providing valuable thought leadership.

– Being dedicated to developing and helping one another and our clients. Our organization is for leaders who want the freedom to do what they think is right.

– Regarding individuals for their competence and leadership, not on their title alone

OUR COMMITMENTS

To assess and leverage the internal and external culture of each organization whilst providing industry and real-world experience.

To build long term relationships with our clients and add value and productivity to each organization we work with.

To do it right the first time by providing the most knowledgeable and well equipped teams for each assignment.

THE WAY WE WORK

Our major objective is ensuring success for our clients. We achieve this by creating teams of key strategists and subject matter experts, problem solvers and staff, who are recognized for their abilities to achieve results.

OUR CULTURE

We value the contributions of each employee and believe success is derived from having teams that reflect a varied and diverse background with new ideas and new perspectives.

OUR EXPERTISE

Our senior consultants have significant experience in successfully taking billion dollar revenue products to market, and working with some of the top ten Biotechnology and Pharmaceutical companies. We have leveraged this experience in helping smaller companies prepare for commercialization of their products and help them further accelerate their regulatory submission time to market.

OUR BELIEFS

We believe in always being professional and achieving results for our clients by:

– Delivering high quality work output on time and providing valuable thought leadership.

– Being dedicated to developing and helping one another and our clients. Our organization is for leaders who want the freedom to do what they think is right.

– Regarding individuals for their competence and leadership, not on their title alone

OUR COMMITMENTS

To assess and leverage the internal and external culture of each organization whilst providing industry and real-world experience.

To build long term relationships with our clients and add value and productivity to each organization we work with.

To do it right the first time by providing the most knowledgeable and well equipped teams for each assignment.

THE WAY WE WORK

Our major objective is ensuring success for our clients. We achieve this by creating teams of key strategists and subject matter experts, problem solvers and staff, who are recognized for their abilities to achieve results.

OUR CULTURE

We value the contributions of each employee and believe success is derived from having teams that reflect a varied and diverse background with new ideas and new perspectives.

ENTREPRENEURSHIP

TEAMWORK & COLLABORATION

PROFESSIONALISM

Our Core Values

RESPECT

EXCELLENCE

INTEGRITY

GIVING BACK TO THE COMMUNITY IS A KEY PRIORITY FOR OUR COMPANY. FIND OUT HOW WE DO OUR BEST TO UPHOLD OUR RESPONSIBILITY WITH ORGANIZATIONS IN OUR COMMUNITIES.

Giving Back to Our Communities

We are actively involved in ensuring our employees and company spend time to help those that require assistance in our communities

Helping Our Neighbors
Lending a Hand
Staying Aware
Feeding Societies

Giving Back to Our Communities

We are actively involved in ensuring our employees and company spend time to help those that require assistance in our communities

Helping Our Neighbors
Lending a Hand
Staying Aware
Feeding Societies

SmileTrain

Many of us here are blessed with happy, healthy families but know that not everyone is that fortunate. So when we heard about Smile Train we realized we were not just giving a child a new smile but in many cases saving their lives, with a surgery that takes just 45mins. There are millions of children with un-repaired clefts who have little to no prospect of ever being helped. Their parents are unlikely to ever be able to afford surgery. So they wait and they hope and they pray that someday, someone will come along and help them.

We have helped children have brighter smiles and brighter futures… and you can too. Click on the link below to find out more.

https://www.smiletrain.org/our-cause

CORA Food Pantry

When our company heard about this program, we were eager to help. We had all heard of the free school lunch program at schools, but had never thought about the holidays. Holidays for children were about beaches and summer programs, not to be going hungry. 3,797 Chatham Country children depend on free or reduced-cost school meals. During the 10 weeks of summer, these same children receive nothing to replace this crucial source of nutrition. Many have no idea where their next meal is coming from when school is not in session. CORA Food Pantry, amongst many of their programs, helps to address the issue of food insecurity in Chatham County, North Carolina. With CORA’s Summer Nutrition Assistance for Chatham Kids (SNACK) will provide ready to eat weekday breakfasts and lunches for 800 of these kids. Every week they receive a package with milk, cereal, fresh fruit and vegetables, and other nutritious items.

Find out more how to help using the link below.

https://www.corafoodpantry.org/our-work/

Durham Crisis Response Centre

RegSource Consulting is proud to be able to help the Durham Crisis Response Center. The Durham Crisis Response Center works with the community to end domestic and sexual violence through advocacy, education, support and prevention.

Their 24 hour crisis line serves as the gateway to all of the shelter and support services offered by DCRC, including case management, counseling, and legal advocacy. Trained advocates are available 24 hours a day to provide support through active listening, crisis intervention, community referrals, safety planning and emergency room accompaniment for survivors of domestic violence and sexual assault. The shelter offers women and children, fleeing violent and dangerous situations, a safe and supportive environment and is a place where they can recover from the effects of domestic or sexual violence.

Find out more at

https://www.durhamcrisisresponse.org/what-we-do

“The Consultants particular strength has been in identifying and implementing state-of-the-art practices to keep up with and anticipate changes in the regulatory environment.”

Senior Director, Top 10 Biotechnology Company

“His extensive background in product development and leadership experience have been instrumental in successfully reaching important milestones over the past few years.”

Senior Director, Vaccines and Immunology, Biotechnology Company

“When you work with him, you have access to over 20 years of strategic therapeutic product development gained in large and small Biotechnology & Pharmaceutical firms, and this is priceless.”

Vice President of Research & Development, Biotechnology Company

“He brings to his consulting work not only the drug development know-how formed from his many years in biotech, but also a sense of team work and dedication. I would gladly work with him again in the future.”

Senior Consultant, Biologics Consulting Group

“I am impressed with his breadth of Regulatory knowledge and experience, as well as the integrity and quality of his Regulatory work. He emphasizes that Regulatory and Compliance should be data driven and the data need to be integral, traceable, and of high quality.”

Vice President of Operations, Biotechnology Company

“We always found solutions to problems and were able to be proactive in anticipating the need for solutions.”

Senior Director Regulatory Affairs, Biotechnology Company

“The RSC Consultant went above and beyond client expectations numerous times to help provide a solution or to suggest enhancements that would streamline processes.”

Regulatory Affairs Consultant, Pharmalink Consulting