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How can ICS help you meet these new regulations?
1. Why use a consultant?
Click here to see how your organization can benefit from a consultant.
That page details how we can provide you with:
a. Temporary Assistance
b. Objective Review
c. Third-Party Request For Problem Identification And Resolution
d. Surviving A Crisis
e. Initiating Change
f. Selecting Personnel
g. In-House Education
h. Dealing With Internal Personnel Difficulties
i. Delay Tactics
j. Executive Assistance
k. Government Regulatory Compliance
l. Socio-Economic and Political Changes
Don’t be "penny wise and pound foolish".
Why spend 1 month internally trying to figure out regulatory / QA / labelling requirements, when ICS can most likely provide the solution in only a few days.
Through our expertise and experience we specialize in saving our customers money, time and frustration.
We can get your product to market faster by efficiently overcoming regulatory barriers and you can start realizing the potential income presently tied up in red tape.
2. Why is ICS Inc. your best choice for NHP services?
a. For our qualifications detailing our experience, training and education, please refer to What are our qualifications for GMP of NHPs?
b. Since we have been working in industries regulated by Health Canada for so many years, one of our key strengths is our ability to take technocratic language, translate it into easy to understand terminology and figure out how to best apply it to your unique situations.
c. We have helped well over 200 organizations (in Canada and throughout the world) with their QA/QC programs, Drug Submissions, Clinical Trials, Labelling materials and Regulatory Affairs issues. These companies range from fewer than 5 people up to some of the world’s largest manufacturers.
d. Over the years we have also developed excellent working relationships with various regulatory authorities (i.e.: Canadian Food Inspection Agency, Health Canada, NHP Directorate, FDA, Australia’s TGA, etc.).
e. ICS has trained over 1,000 people and has presented at a wide variety of conferences.
f. We have also been successful in linking Canadian manufacturers with foreign marketers (and vice versa).
g. Due to our ever-expanding range of industry contacts, we are uniquely positioned to provide referrals to pre-qualified service providers (such as: raw material & equipment suppliers, commercial labs, contract researchers / manufacturers / processors / packagers / labellers, brokers and translators).
h. We have developed and continually refined both our general and specific training courses on Quality Assurance (i.e.: GMP, GLP, GCP, HACCP, etc.). These courses are also routinely updated to include the constant changes to the regulatory environment and technological & scientific advances within the industry. These training sessions are presented as open seminars and as company-tailored programs.
3. Our Product Licence Application (PLA) services
We can:
a. Ensure the medicinal ingredients (MIs) are allowed in NHP formulations.
b. Ensure the non-medicinal ingredients (NMIs) are on the "List of Pre-approved NMIs".
c. Ensure the NMIs are the least toxic available, and justifying their purpose in the formulation.
d. Ensure the manufacturer meets all of the GMP requirements for NHPs.
e. Identify the type and category of health claim(s) in the PLA and on the label, such as: risk reduction vs. structure-function (specific vs. non-specific) vs. treatment vs. traditional use vs. non-traditional use.
f. Locate, then obtain, the scientific documentation to support the Safety, Efficacy & Quality – not only for the Finished Product, but also for each individual MI. Please refer to our Literature Search services.
g. Ensure the types of documentation used in the PLA are from reputable sources which the NHPD will recognize. Please refer to our Literature Search services.
h. Create a Quality Summary Report for each MI, which explicitly describes:
i. the manufacturing process for each MI (including extracts);
ii. any sterilization and/or irradiation processes;
iii. the analytical methods to test the finished product;
iv. the validations of the analytical methods;
v. justifications on the specifications for the finished product (including: determining which test should be performed and which tests are not required); and
vi. the format and information within the C of A
i. Create an Efficacy Summary Report for each MI and for the finished product, which explicitly references various scientific literature and describes the:
i. Human, animal and in vitro studies;
ii. Clinical trial data;
iii. Pharmacokinetics, pharmacodynamics, & toxicity studies;
iv. Reproductive, genotoxicity & carcinogenicity data; and
v. Justifying (in a format acceptable to the NHPD), the purpose for combining more than one MI into a single product.
j. Create a Safety Summary Report for each MI and for the Finished Product, which explicitly references various scientific literature and describes:
i. Risk information, such as required listing of: cautions, warnings, contraindications or known adverse reactions;
ii. Herb-herb, herb-drug and herb-food interactions;
iii. Whether the MIs and/or NMIs interfere with QC or diagnostic tests;
iv. Safe dosage ranges and duration of use;
v. Additive pharmacological (beneficial) effects of two or more like-acting (or synergistic-acting) MIs in the same product;
vi. Additive adverse reactions due to two or more MIs in the same product;
vii. Performing numerous combinations of calculations to ensure that the additive pharmacological effects clearly outweigh the additive adverse reactions; and
viii. Providing a rationale (in a format acceptable to the NHPD), on how to mitigate any risks associated with each MI or their combination.
4. Our Literature Search services
a. Since we have been working in this industry for many years now, we have a very good idea of what types of literature, the NHPD will find acceptable and which literature may not be.
b. Over the years we have purchased numerous reference books which are acceptable to the NHPD. Therefore, we may have the necessary literature on hand.
c. We also pay annual subscription fees to various electronic literature sources, which are acceptable to the NHPD.
d. Overall, we should not only be able to find literature which is acceptable to the NHPD, but we should be able to obtain it in a rather efficient manner.
5. Our Label Development services
We can ensure your labels meet the NHPD requirements for format and information, such as:
a. Ensuring the label information exactly matches the PLA documentation;
b. Ingredients are listed in the correct order and use of their proper terminology;
c. Determine the appropriate Quality Control testing necessary for your product, and recommending only those tests that are absolutely required, thereby saving you time and needless expense;
d. Provide you with a list of qualified and reputable labs to carry out required product testing (some labs excel at some tests while other labs will be better at other tests);
e. Appropriate directions for use;
f. How to correctly include all of the Risk Information;
g. Correct units for each MI (mg, mcg, IU, mL, etc.);
h. Determining which marketing / advertising claims are allowed and which ones are not;
i. Which info must be on the front panel of the label and which info can be on any other panel;
j. Correct font sizes for each heading on the label;
k. Which headings and/or statements must be in bold;
l. Ensuring the proper format & location for the expiry date and lot number;
m. Which terms or phrases must be bilingual and which ones are optional; plus
n. Many, many other label issues which must also be addressed – some of which were not required for similar products under the DIN application process, or under the old Food Supplement regulations.
6. Our Site Licence Application(SLA) services
a. One large part of the Site Licence application is that one submit a Quality Assurance report outlining your GMP program in detail.
b. For each section of GMP, we can list all relevant Standard Operating Procedures (SOPs), and attach samples of records used to demonstrate adherence to those SOPs.
c. This documentation must then be attested to, by a QA person who meets the NHPD’s qualifications for education, training & experience. See Our Qualifications.
d. We will ensure your foreign sites meet the NHPD regulations for GMP. See our Internal and Third Party GMP Auditing services.
7. Our GMP Implementation & Training services
ICS Inc is quite qualified to:
a. Provide an objective and unbiased review, to assess conformance of your operations to the regulations, and determine the level of implementation & effectiveness of the requirements.
b. Identify opportunities for improvement, within the scope of the system requirements.
c. Conduct an assessment of your present GMP system and procedures;
d. Perform a "Gap Analysis" to determine the deficiencies
e. Provide a general overview of the NHP regulations and GMP for Management and Staff.
f. Assist with writing and revising the policies, procedures, forms, checklists, internal labels, etc.
g. Develop your mandatory Quality Assurance Report for PL applications.
h. Select and coach personnel involved in the implementation process.
i. Provide detailed training to individual departments, regarding specific GMP requirements.
j. Conduct the Internal Audit and assist with implementing the required corrective actions. (See our Internal Auditing services.)
k. Liaise with the NHPD on your behalf; and
l. Perform regular follow-ups thereafter, or act as your Quality Assurance Officer, when requested. (See our QA Officer Services).
8. Our Internal and Third-Party Auditing Services
a. It is important to employ a third-party auditor who is properly qualified for the work. Therefore, please note that the NHPD has specific requirements for the education, experience and training of those personnel who perform the following functions. (See Our Qualifications.)
b. We have the integrity and ethics as well as an awareness of existing and potential conflicts of interest; these traits are necessary to do an effective and credible audit.
c. According to the GMP regulations, auditors must have the following qualifications, which all of our staff meet:
d. Education: Four-year degree in science or equivalent from a recognized institution, including (but not limited to): biochemistry, biology, chemistry, microbiology and pharmacology.
e. Training: Food, NHP or pharmaceutical GMP; Food and Drugs Act; Natural Health Products Regulations; Complementary and alternative medicine; Roles and responsibilities of international, national and provincial/territorial players in the food, NHP and drug regulatory arena; NHP safety; Quality assurance and control operations; GMP audits; HACCP or ISO audits; Sanitation programs; and Pest management.
f. Experience: Three years experience in GMP audits in the food, NHP and/or pharmaceutical industry; Three years experience in quality assurance in the food, NHP and/or pharmaceutical industry; Manufacturing or production of food, NHPs and/or drugs; ISO or HACCP lead audits; In a regulatory environment involving activities such as compliance and enforcement; process and product evaluation; GMP inspection; consumer and trade complaint investigation; and laboratory analysis.
Third-Party GMP Audits of your suppliers and contract manufacturers
a. As part of your "due diligence", ICS can let you know whether or not your suppliers and/or contract manufacturers are meeting not only their GMP requirements, but also their contractual agreements, no matter where they are located throughout the world. These suppliers may include contract manufacturers and/ or testing laboratories.
b. No matter where your suppliers are located, we can most likely provide these services at less travel expense. This is due to our network of strategic alliances or subcontracted auditors, or we may also have other clients in the city that your supplier is located. [click here to see more detailed information]
9. Our QA Officer Services
a. Over the past 5 years, we have been routinely performing these services for many small to mid- sized operations. Typically, these services are (but not limited to):
b. QC test results: review & approval. (See our page on why we will not have our own QC test lab.)
c. GMP audits of your facilities and/or your suppliers’ facilities.
10. Our Marketing and Advertising Services
a. The NHPD considers your leaflets, brochures and website to be extensions of your label! This is especially true if you list your web site on your product label.
b. As such, all of your marketing & advertising materials must be compliant to the NHP regulations.
c. ICS can ensure that all of your materials meets these regulations.
d. Furthermore, our market research can provide you valuable information. For example, do you want to know:
Is the sales volume trending upwards for the "Vitamin Supplement" that you are considering carrying?
Is the market share for tincture products increasing over those in capsule form?
How are the sales of probiotics doing, compared to amino acid supplements?
Which countries have increasing sales volumes of Joint Support products and which countries are in decline?
Where are the majority of Herbal and Vitamin & Mineral supplements sold? (Big Box grocery stores? Health Food stores? Internet? Multi-Level-Marketers?)
Who are the most likely purchasers of your essential fatty acid supplement or herbal formulation? (Men between 18-35 or women who are 50+)?
What are the decision factors that consumers take into consideration when purchasing a Natural Health Product? (cost?, advertising?, brand name? health claims? information on the label?)
e. Since we subscribe to numerous electronic scientific newsletters from around the world, we are routinely informed when the latest market research findings are to be published and the cost(s) and availability (ordering timelines, etc.) of each publication.
11. Our services for locating sources of funding
a. We only focus on funding programs for industries regulated by Health Canada and the Canadian Food Inspection Agency (CFIA).
b. For a more detailed description of the information below, please go to our Funding page.
c. The Funding web page discusses items such as:
i. Developing project ideas where funding may be allowed and areas where funding is not, such as:
ii. research into product safety, quality & efficacy;
iii. optimizing growing conditions;
iv. GMP training and implementation;
v. facility and equipment design/upgrades;
vi. attending and presenting at conferences and trade shows;
vii. improvement (or development) of labels, advertising & marketing materials, and website to obtain regulatory compliance;
viii. hiring and training new staff; and
ix. market research.
d. Identifying the various municipal, provincial, federal and private funding programs which may be available to your company.
e. Assisting with the technical aspects of the various grant and subsidy applications.
f. Estimating percentages for potential of success on each grant or subsidy application
g. Estimating monetary values of each successful application.
h. Technical liaison with the Grant application personnel, on your behalf (if you wish).
12. Innovative pricing and billing schedules for small or start-up operations
a. We know that implementing these new regulations for product licencing, label development, marketing & advertising compliance, site licencing, GMP implementation, etc, can be quite a hurdle for small companies and start-ups to overcome.
b. Because we are sensitive to these obstacles, we have implemented a flexible pricing & billing strategy which we may allow for certain pre-qualified clients. Examples, may include:
c. Charging only a certain up-front % (retainer fee) to complete the project. For example charging only 75% of our rates for Product Licence Applications (and their corresponding labels). Then, once the small client is generating revenues from these new & improved labels, the client finishes paying the remaining 25% of outstanding fees, plus an additional % to us for carrying those outstanding fees and carrying those risks of not being paid the final 25%.
d. In other situations, we may forgo the full fees, in lieu of a % of all future potential sales in the first few months or years.
e. Please note that our high level of ethics will not allow us to bend rules or regulations, or turn a blind eye, in order to ensure your products or site get approval by the NHPD, for the sake of our goals of receiving any post-marketing %.
13. Other services worth noting
a. Due to our ever-expanding range of industry contacts, we are uniquely positioned to provide referrals to pre-qualified service providers, such as: raw material & equipment suppliers; commercial labs; contract researchers; contract manufacturers, packagers & labelers customs broker; language translators with technical backgrounds;
b. We have also been successful in linking Canadian manufacturers with foreign marketers (and vice versa).
14. Request a quote from us
a. Please refer to our innovative pricing schedules for small or start-up operations.
b. Please contact us, either by phone, fax or email. (Contact Us)
c. We will then issue you our standard Non-Disclosure Agreement (NDA), so that your information is properly secured by us.
d. Upon receipt back to our office of the signed NDA, we will then send you a list of questions about your product so that we can provide you as accurate quote as possible. This list of questions will be such as: list of all medicinal & non-medicinal ingredients, their concentrations, samples of any labels, etc.
e. Upon receipt of this confidential information, we can then use our internal 95 point MS Excel spreadsheet to provide you as accurate quote as possible.
f. Since we perform this service on such a routine basis, we should be able to provide a quotation within 72 hours.
g. We provide discount rates for bulk services when we can dedicate more than one week at a time to a specific project, and/or when clients pre-book our services to perform a few PLAs each month, for many months.
What are our qualifications for GMP of NHPs?
The NHPD requires that the QA person meets specific qualifications for:
Quality Assurance training
Training in Auditing
Experience in Auditing
Science background
NHP industry experience
(See About Us)
Links to important websites
Natural Health Products Directorate (NHPD)
ICS Notice to industry stakeholders explaining the complexity of performing PL Applications (and thus the amount of time required)
1. This letter explains the complexity of performing PL Applications (and thus the amount of time required).
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