Demberg PharmaSolutions
Solving Quality and Compliance Challenges

Pharmaceutical and other life sciences organizations distribute existing products, develop, and launch new products to meet the patient community’s evolving needs. Regulatory requirements are specific to each step of the product lifecycle and vary for different product types such as pharmaceutical, medical devices, biological etc. Additionally, all regulations are constantly revised by regulatory bodies. These circumstances make the product development and commercialization process long and arduous, especially while a company’s portfolio grows with new product types. Life science organizations end up reacting to these developments rather than creating a scalable quality system that could be adapted to the new requirements.

Demberg PharmaSolutions (DPS) changes the status quo for its clients with robust and strategically built quality management system designed to facilitate the shift from reactive to proactive. DPS works with life sciences and healthcare organizations as a consulting arm to help them stay one step ahead of the changing reality and ensure their products and processes always meet the requirements of regulatory authorities. DPS changes clients’ mindset by educating them on the regulatory and compliance benefits of quality.

“Our mission is to promote quality standards and quality culture in the pharmaceutical and other sectors of life sciences space to strengthen the quality approaches, policies and procedures in accordance with current regulatory requirements and our clients’ business objectives, marketing strategies, and customer needs,” says Natasha Demberg, founder and president of Demberg PharmaSolutions.

DPS promotes a partnership between quality, manufacturing, and business functions by shifting quality role in the organisation from a cost-center to cost-saving. DPS believes in quality as a business partner that can efficiently support business needs along with the regulatory compliance.

This synergy between quality and business aspects ensures development and commercialization speed is balanced with quality and regulatory compliance.

Making pharmaceutical and life sciences organizations quality-centric begins by training the upper management, who becomes the active drivers of change. Problems are addressed from the client’s viewpoint. Demberg PharmaSolutions thinks five steps ahead, so clients will have all their bases covered from a quality and compliance point of view.

Demberg PharmaSolutions generates value by creating and supporting strategically built quality systems, compliant to Canadian, USA, and EU cGXP regulations and promoting a quality-oriented culture. The key is to gain a detailed understanding of every department’s roles, responsibilities, and their interconnections, and to create a lean and logical compliant organisational structure. This understanding forms one of many DPS’s consultation offerings.

Demberg PharmaSolutions’ excellence can also be attributed to Natasha Demberg’s expertise in helping life sciences, and healthcare sectors meet their quality assurance and compliance management goals for pharmaceutical, medical devices, natural health, and biological products. Her ability to think strategically, dynamic leadership style, and creativity underpin the firm’s ability to exceed client expectations.

In one instance, a Canadian distribution company sought Demberg PharmaSolutions’ help to regain their licence to distribute pharmaceutical products and to establish a pharmaceutical quality management system in their infrastructure. Previously, an equity firm acquired them and did not follow through with the action plan communicated to Health Canada after the last inspection, that resulted in the suspension of their licence. The company distributed Medical Devices and Pharmaceutical products. A major drawback for the client was that they did not consider the importance of quality evaluation during the due diligence process. The company was not aware of the different regulations related to each type of products in its portfolio. In addition, they were unfamiliar with good manufacturing practices (GMP) and did not have the appropriate quality system to navigate pharmaceutical industry regulations. Demberg PharmaSolutions provided an efficient pharmaceutical quality system tailored to their existing business needs, and fulfilled all previous promises made to Health Canada. This resulted in the compliant Heath Canada inspection rating, regaining the licence, and establishing an effective business operation.

With over 30 years of experience of managing quality assurance and compliance in a regulated environment, Demberg PharmaSolutions is well placed to offer professional and robust support in all possible situations. Whether it’s an emergency or an everyday needs, DPS supports its clients to ensure their products and systems always meet the requirements of regulatory authorities and helps them focus on launching and distributing the best products possible.