The easiest way toward product licensing.

Since the promulgation of the natural health product regulations in Canada in 2004, prophema has helped hundreds of clients world-wide and submitted thousands of NHP product license applications (PLAs) to the Natural Health Products Directorate (NHPD) of Health Canada. We have developed all the expertise needed to make the licensing process smooth sailing, and our success rate in product licensing is well above the average, leading to our recognition as the go-to NHP regulatory consultant.

We are experienced in multiple product types, including submissions for traditional, non-traditional, homeopathic, combination and compendial products, and in all submission categories, including plant or animal materials, extracts, isolates, synthetics, probiotics, and enzymes.  

Our services in Natural Health Products Licensing:

• Initial product classification 
• Ingredient Issue form preparation
• Safety and Efficacy reporting and documentation
• Finished product specs and quality summary reporting 
• Draft label creation
• Submissions in ePLA format
• Filing notifications and amendments
• Responding to government Clarification Requests (CRs)
• Responding to government Information Request Notices (IRNs)
• Preparing Master File Applications
• Arranging pre-submission meetings with the NHPD

Your brains trust for product development and claims substantiation

Not only do we employ a body of qualified professionals with top-class credentials in human health sciences, we also have an exhaustive and constantly updated repository of thousands of full-text research papers. This gives us the knowledge we need to help our clients in developing their products and evaluating their health claims for natural health products.

In the area of natural health products, many companies that use novel ingredients or make unique claims submit their product license applications without substantiating their safety or efficacy. As a result, the NHPD denies them a license. Involving prophema early in the product development processes protects you from any potential hurdles that result from unsupported product claims, and enables you to develop a successful license application. 

Our services in NHP Health Claim Substantiation Assessment and Product Development:

• New product formulations
• Substantiation of therapeutic and health claims
• Development of safety and toxicological profiles
• Preparation of formula combination rationales
• Product monograph preparation for professional consumption
• Application and maintenance of projects under the Canadian Scientific Research and Experimental Development (SR&ED) program
• Arranging pre-submission meetings with the NHPD
• Scientific and medical writing

Secure your site in a compliant manner

All domestic Canadian companies who manufacture, package, label or import a natural health product for sale may do so only in a licensed site. The Natural Health Products Directorate issues these site licenses, and even foreign manufacturers must be annexed to the site license of a Canadian importer. prophema has assisted several companies in site licensing, all of whom have gone on to get their required licenses. 

Whether you are a manufactuer, packager or importer, our quality and compliance experts will assist you in all aspects of site licensing and guide you through the licensing process. 

Our services in Natural Health Products Site Licensing:

• Development and implementation of GMP-compliant quality system. 
• GMP Audits
• QA report preparation
• Site licence application dossier preparation
• Site license renewal applications (aka summary of net changes dossiers)
• Site license amendments
• Site license annexations for foreign sites
• Foreign Site Reference Number (FSRN) applications
• Responding to government information request notices (IRNs)
• Arranging pre-submission meetings with the NHPD

Ensure you follow good manufacturing processes for NHPs

GMP compliance is a hard requirement for any company in the NHP manufacturing field, including packagers, labelers and importers. NHP GMPs are set out in part three of the Natural Health Products Regulation, which lists the appropriate processes, procedures and documentation for all activities related to the making of natural health products. Regulations also cover distributors, who are responsible for meeting specific GMP requirements. 

All companies should have a quality assurance person who is well-credentialed, experienced, and well-trained, and prophema can fill this pivotal role for you. GMPs apply even during the post-marketing stage in Canada, and good manufacturing practices double as excellent quality and risk management strategies. prophema can provide you with both formal QA personnel or with informal advise on quality assurance issues. 

Training in good manufacturing processes is mandatory in Canada for all companies in the NHP chain, from manufacturers to importers, and prophema has a sterling track record in providing the best GMP training available in the NHP sector. Our services deal specifically with the development and implementation of a GMP-compliant quality system, or with improvements to your current system through various measures.

Our services in NHP GMP compliance:

• Creating and revising standard operating procedures
• Drafting technical agreements
• Devising stability protocols 
• Finished product specification review
• Creation of Complaint handling programs
• GMP Audits
• Custom designed GMP training 
• GMP Training
• Quality Assurance Reports (QAR), and Foreign Site Reference Numbers Applications for international manufacturing, packaging, and labeling facilities

Ongoing Quality Assurance:

Ongoing Quality Assurance

• Quality assurance for finished products for sale
• Investigation of complaints, deviations and non-conformities
• Evaluation of product returns
• Change Control Assessment

Arm yourself with the best-qualified suppliers

NHP manufacturers should make sure to qualify their suppliers of raw materials so that there is greater confidence in the supplier-issued certificates of analysis. This will prevent supply chain problems and ensure the product remains traceable. Raw material suppliers are not covered by GMPs, and manufacturers must bear the onerous and expensive task of qualifying their raw material suppliers. At prophema, our team of experts is qualified to assess your suppliers’ GMP compliance, allowing you to focus on day to day business activities. 

Our services in Supplier Qualification:

• 3rd Party Audits of raw material suppliers
• Creating audit plans and checklists for raw material suppliers 
• Devising SOPs for supplier qualification 
• Devising SOPs for raw material lots that fail testing
• Requalification of existing suppliers
• Classification of suppliers by risk
• Certificate of Analysis (COA) content and format recommendations and verification
• Review of supplier quality systems and testing methods for GMP compliance
• Drafting of GMP contracts

Import from the best, through prophema

The Canadian market is enriched by the variety of natural health products imported from abroad. However, many foreign companies that want to sell their health products in Canada do not have the regulatory permits required for import, and choose to outsource quality assurance to third-party players. prophema is one of the few regulatory advisors that possesses its own site license to import NHP’s into Canada. 

Our services in in Natural Health Products Importation:

• Legal importation under prophema’s site license
• QA for product release
• QA for handling of returns
• QA for investigation of complaints, deviations and non-conformity
• GMP-compliant storage of natural health products 
• Logistics and fulfillment
• Customs brokerage services

Substantiate your safety and health claims for NHPs and ingredients

NHP trials provide evidence that supports the health claims made for a certain ingredient or product. They also make the case for altered dosages and new health claims. prophema has assisted several NHP firms in their clinical trial application submissions to Health Canada.

Our services for NHP clinical trials:

• Protocol design and review 
• Clinical trail monitoring
• Multi-centre trial management
• Regulatory submissions
• Customized CRF / source document design
• GCP compliance auditing

Let us help you with adverse event reporting

In Canada, product license holders for both drugs and natural health products are required by law to provide Adverse Reaction Reporting. The law is expected to cover foods and cosmetics as well in the future. Few companies have the know-how to meet this requirement, which is why prophema is here to assist you in Adverse Reaction Reporting with its scientific and regulatory experience, and minimize your legal exposure in this context. 

Our services in Adverse Reaction Reporting:

• Adverse reaction evaluation and classification
• Guidance on how, when, and where to submit serious adverse reaction reports
• Preparation of adverse reaction case reports
• Preparation of adverse reaction annual summary reports for Health Canada and the Marketed Health Products Directorate (MHPD)
• Record maintenance for serious and non-serious adverse reactions
• SOP for call center reps on completing ARR forms 
• Creation of templates for Customer Complaints