Services

Our experts can assist you with several aspects of your business, enabling you to concentrate on the growth and future of your company. Whatever the challenge facing you may be, whether it be a regulatory, scientific or customer care issue, we can help you find an efficient and innovative solution. Our areas of expertise include, but are not limited to, the following services:

Product Development and Scientific Support
International Regulatory Compliance
Importation Support
Protection of Intellectual Property Assets
Regulatory Due Diligence
Clinical Trial Design & Maintenance
Training & Education
       Customized Training Programs
Consumer Response Service

Product Development and Scientific Support

From concept to shelf, dicentra can assist and advise you on how to bring your products to market. We will work with you to determine optimal product positioning and marketability, and offer complete scientific evaluations for product development and maintenance. Our services include:

• search and review of scientific literature
• new product development and formulations
• composition of monographs for consumers and professionals
• risk assessments
• safety and efficacy evaluation
• health claim substantiation
• determination of contraindications and warnings
• identifications of drug and natural product interactions
• toxicology evaluation

We maintain and continually upgrade a comprehensive database of compiled scientific evidence, including tens of thousands of full-text papers and related copyright licenses. Our in-house experts can conduct rapid database searches on specific ingredients and formulations for the fast compilation of supporting evidence, resulting in the quickest route to the development of successful products. With these services dicentra assists today’s industry-leading companies to develop safe, effective and market-leading products and consequently increase consumer trust and sales.

Back to top.



International Regulatory Compliance

Along with its headquarters in Canada, dicentra maintains affiliates in many countries around the world, offering a specialty in international product compliance and registration. dicentra can help you navigate the complex world of diverse regulations and simplify the introduction of your products to markets outside of their current home.

For Canada in particular we offer services for product registration, Good Manufacturing Practice (GMP) compliance, and Site Licensing.

Since the introduction of the Natural Health Products Regulations in Canada in 2004, dicentra has successfully advised hundreds of clients around the world and filed thousands of submissions to Health Canada for product licenses. We continually exceed the industry’s average percentage success rate in obtaining Natural Product Numbers (NPNs).

For GMP Compliance and Site Licensing dicentra's experts conduct on-site qualified audits recognized by Health Canada to ensure that all steps in your manufacturing opeartions [CGT1] meet the strict GMP requirements. We also offer services for Standard Operating Procedures (SOPs) composition, site auditing, preparation of Quality Summary Reports (QSRs), and on-site training and educational support for your personnel to ensure that you obtain and maintain a valid Site License.

Back to top.



Importation Support (Canada)

Nearly fifty percent of the Canadian adult population uses a natural health product on a daily basis. Successfully bringing your product to the Canadian market could easily result in a substantial increase of your sales. dicentra actively maintains a Site License from Health Canada for the importation of natural health products into Canada. With a Site License and an affiliated fulfillment house, dicentra can simplify all of your export, quality, regulatory, and logistic needs to ensure that you can take full advantage of the lucrative Canadian market.

Back to top.



Protection of Intellectual Property Assets

dicentra can assist industry members in protecting their valuable Intellectual Property assets. We can prepare patent and trademark applications, conduct investigative searches (for domestic and international approved and pending applications) and assist in finding the best available routes for creating and monitoring a solid and successful Intellectual Property portfolio.

Back to top.

Regulatory Due Diligence

Regulatory problems can be a significant drain on personnel and financial resources when they arise unexpectedly. For this reason, it makes good business sense to conduct regulatory audits and continually practice regulatory due diligence within your company. Mergers and acquisitions can lead to the discovery of regulatory inconsistencies which can lessen the value of an entire product line or business. Some examples of these inconsistencies would be incomplete or limited product approvals, inadequate complaint-handling systems, inconsistent labelling, or non-compliant manufacturing processes.

The experienced team of professionals at dicentra can efficiently and thoroughly conduct these regulatory audits and help you employ regulatory due diligence. Our techniques will increase the value of your assets and lessen the business and financial risks associated with mergers and acquisitions.

Back to top.

Clinical Trial Design & Maintenance

Companies are having great difficulty obtaining product licenses for the health claims they want. Additional evidence is often required to substantiate the effectiveness of a specific formulation. dicentra can guide you in the right direction by designing and conducting a clinical study to support your claim. dicentra works with contacts in the academic field to conduct small population based trials to provide solid scientific support for your desired health claim.

Don’t let the reported cost of Phase III pharmaceutical trials put your research on hold. Natural health product trials cost much less. dicentra can also help reduce the cost of your research program by preparing a successful Scientific Research and Experimental Development claim (SR&ED) to ensure maximum returns.

dicentra can provide you with a full range of scientific and regulatory support for all your clinical research needs, including consultation with your marketing and research teams to identify desired health claims, gathering and reviewing supporting safety and efficacy evidence, formulating products to target a specific health claim, designing and preparing a clinical trial protocol to support a specific health claim, and submitting all appropriate regulatory and ethics documentation for government approval.

Back to top.



Training & Education

We offer education seminars, presentations and work groups to educate you, your employees and others who require a knowledge base of scientific or regulatory issues. dicentra’s scientific and regulatory experts can visit your company and provide an on-site training session. We also regularly host live e-training sessions. For a schedule of upcoming sessions or to purchase a previous educational seminar please visit Training.

Customized Training Programs (CTPs)

In addition to our training seminars, dicentra can provide tailor-made training programs based on your company’s needs. The programs can cover particular topics and problems that you would like to see addressed, while being specifically suited to your product line, as well as your employees’ roles and responsibilities. The program and its accompanying reference materials will be designed exclusively for your company by our experienced team of professional consultants.

Based on your preferences, dicentra can partner with you to prepare and implement your training strategies or bring our training workshops directly to your workplace. We guarantee performance improvement and the acquisition and application of knowledge through the increased relevancy and interaction that comes with a custom-made training program.

Back to top.

Bilingual Consumer Response Service

Consumers offer a wealth of information which is often overlooked by manufacturers and distributors in all industries, including natural health products. A direct line of communication between the end users of your products and your own decision makers has numerous benefits. At dicentra, we can assist and advise you on how to take advantage of the opportunities and information your consumers can provide to you. Through efficient communication and record keeping, we promise to ensure regulatory compliance, particularly with regards to adverse reaction reporting, while maintaining and supporting your branding and marketing needs. The ultimate goal is to increase consumer loyalty and thus increase your sales.

This new service offers companies the opportunity to differentiate themselves from the competition by providing a bilingual human point of contact where your consumers can have their questions answered and their needs met. Drawing on the resources of dicentra’s talented team of professionals, and a streamlined communication and data collection system, this service promises results beneficial to both consumers and our clients.

Back to top.