Primary Profile

Innovative Consulting Solutions Inc.

Innovative Consulting Solutions Inc.

Innovative Consulting Solutions Inc.

1041 White Rd
South Slocan, British Columbia
V0G 2G0

P.O. Box 68
South Slocan, British Columbia
V0G 2G0

(250) 359-7873

(250) 359-7874

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Innovative Consulting Solutions Inc.

ICS Inc. is a team of Quality Assurance (QA) & Regulatory Affairs specialists.
We are a consortium of chemists, biochemists, biologists and microbiologists.
We aid developers, manufacturers, packagers, labeller, marketers and importers / exporters to meet their legal requirements. Our focus is on the pharmaceutical, nutraceutical, cosmeceutical, cosmetic, food, functional food, feed, natural health product (NHP), chemical and medical device industries.

Company Details

1999

6

Canada

Yes

541690 - Other Scientific and Technical Consulting Services

311119 - Other Animal Food Manufacturing
325410 - Pharmaceutical and Medicine Manufacturing
334512 - Measuring, Medical and Controlling Devices Manufacturing
414510 - Pharmaceuticals and Pharmacy Supplies Wholesaler-Distributors
541380 - Testing Laboratories
541612 - Human Resources Consulting Services
541620 - Environmental Consulting Services
541710 - Research and Development in the Physical, Engineering and Life Sciences
541940 - Veterinary Services
541990 - All Other Professional, Scientific and Technical Services
561320 - Temporary Help Services
611430 - Professional and Management Development Training

Services

Product / Service / Licensing

Service Name: Quality Assurance (QA) Consultant
Design, implement and audit QA programs such as: GMP (Good Manufacturing Practices), GLP (Good Laboratory Pracitices), GCP (Good Clinical Practices), HACCP (Hazard Analysis and Critical Control Point), ISO 17025 and ISO 13485.

Ensuring all ingredients, formulations, labels and marketing information are compliant to Health Canada, FDA, TGA, etc.


Service Name: Pharmaceutical Regulatory Consultant
Quality Assurance (QA):
GMP, cGMP, GLP, and GCP
Audits, training, implementation, SOPs,
Equipment Validations and Process Validations
Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ)
Regulatory Affairs:
Drug Submissions (DINs)
Scientific literature searches to support DIN applications
Evaluating and coordinating Clinical Trials and their protocols
Ensuring all ingredients, formulations, labels and marketing information are compliant to Health Canada, FDA, TGA, and other Health Authorities.
Drug Establishment Licences (DELs)

Service Name: Natural Health Product (NHP) Consultant
Quality Assurance:
GMP implementation, training and audits
SOP writing
Site Licence applications
Regulatory:
Product Licence Applications
Scientific literature searches to support health claims for safety, quality and efficacy
Ensuring all ingredients, formulations, labels and marketing information are compliant to Health Canada's Natural Health Products Directorate (NHPD)

Service Name: Food Regulations Consultant
Regulatory:
Ensuring all ingredients, formulations, labels and marketing information are compliant to Canadian Food Inspection Agency (CFIA).
Quality Assurance (QA):
Design, implement and audit Food QA programs such as HACCP and GMP.
SOP development

Service Name: Cosmetic Regulatory Consultant
Ensuring all ingredients, formulations, labels and marketing information are compliant to Health Canada.
Registration services
Quality Assurance (QA):
Design, implement and audit their QA programs such as GMP.
SOP development.

Service Name: Regulatory Affairs Consultant
Product registrations for: Pharmaceuticals / Drugs (DINs), Natural Health Products (NPNs), Cosmetics (Notifications).
Ensuring all ingredients, formulations, labels and marketing information are compliant to Health Canada, NHPD, CFIA, FDA, TGA, EU, UK, etc.

Service Name: Dairy Products Consultant
Dairy Establisment Licencing for manufacturers / processors of dairy ingredients such as whey protein isolates & concentrates.
Ensuring all ingredients, formulations, labels and marketing information are compliant to Health Canada, Canadian Food Inspection Agency (CFIA), FDA.
Quality Assurance (QA):
Design, implement and audit their QA programs such as HACCP and GMP.

Service Name: Mecical Device Consultant
Quality Assurance:
Dsign, implement and audit Quality Assurance (QA) programs such as ISO 13485, ISO 13488 and GMP.
SOP development, review and evaluations.
Regulatory:
Determining device Class I - IV
Medical Device Licences
Ensuring all ingredients, components, labels and marketing information are compliant to Health Canada and FDA.

Service Name: Nutraceutical Regulatory Consultant
see Natural Health Product services


Service Name: Dietary Supplement Consultant
see "Natural Health Product" services


Service Name: Functional Food Consultant
see Food Consultant services

see Natural Health Product Consultant services


Service Name: Novel Food Consulant
Regulatory Affairs:
Evaluating and coordinating the Clinical Trails for product quality, safety and efficacy.
Clinical Trial protocol development, review and evaluation services.


Service Name: Nutritional Supplement Consultant
see "Natural Health Product" services


Service Name: Label Development Consultant
We can ensure your labels meet the requirements for format and information, relating to: Food / Functional Food, Drug / Pharmaceutical, Cosmetic, Medical Device, Natural Health Product / Dietary Supplement / Nutritional Supplements, such as:

1. Ensuring the label information exactly matches the product registration documentation;

2. Ingredients are listed in the correct order and using the proper terminology;

3. Determine the appropriate Quality Control testing necessary for your products, and recommending only those tests that are absolutely required, thereby saving you time and needless expense;

4. If requested, provide you with a list of pre-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);

5. Appropriate directions for use;

6. How to correctly include all of the legally required Risk Information (cautions, warnings, contraindications or known adverse reactions);

7. Correct units for each ingredient (mg, mcg, IU, mL, etc.) and/or correct dosage instructions;

8. Determining which marketing / advertising claims are allowed and which ones are not (as well as the specific wording which is allowable);

9. Which info must be on the front panel of the label and which info can be on any other panel. (Please be aware that: in some situations Health Canada may view your web site content as an extension of your label. As such, the web site must also be compliant);

10. Correct font sizes for each heading on the label;

11. Which headings and/or statements must be in bold;

12. Ensuring the proper format & location for the expiry date and lot number;

13. Which terms or phrases must be bilingual and which ones are optional;

14. If requested, perform all legally required French translations.

Service Name: Scientific Literature
Our specialty is converting Scientific literature into non-technical documentation.

Scientific / Technical literature searches to support a product's claims for safety, efficacy and quality.

Evaluation of customer-supplied Scientific / Technical literature and prepare expert opinion reports on that literature.


Service Name: Herbal Consultant
see our "Natural Health Product" services


Service Name: Botanical Consultant
see our "Natural Health Product" services


Service Name: Regulations Consultant
If you ever need a copy of a specific regulation relating to Health Canada's Food and Drug Act or its Regulations (FDR), or the FDA's Code of Federal Regulations (CFR), or Canadian Food Inspection Agency (CFIA) regulations on Marketing & Advertising, or any of the above authorities' Policies, Directives, Guidelines, Guidance documents, forms and the like - we most likely have them !!!

If we don't have them, we know how to obtain them in a very short time.


Service Name: Funding Consultant
We can help organisations locate and apply for grants, subsidies and loans specific to the Pharmaceutical, Nutraceutical, Cosmetic, Cosmeceutical, Food, Functional Food, Feed, Medical Device and Natural Health Product (NHP) industries.

This may apply to clinical trials, product registrations, trademark & patent issues, marketing strategies, business plan development, quality assurance (QA) training and regulatory compliance issues.

We can:

1. Perform a thorough review of your present operations in order to develop project ideas where funding may be allowed and areas where funding is not.

2. Identify the various municipal, provincial, federal and private funding programs which may be available to your company.

3. Assist with the technical aspects of the various grant and subsidy applications

4. Estimate percentages for potential of success on each grant or subsidy application.

5. Estimate monetary values of each successful application.

6. Be the Technical Liaison with the Grant application personnel, on your behalf.


Service Name: Clinical Trial Consultant
Development, evaluation and coordination of Clinical Trials for: Novel Foods, New Dairy Ingredients, Pharmaceuticals, Natural Health Products (NHPs) and Medical Devices.


Service Name: ISO 13485 Consultant
see our "Medical Device Consultant" services


Service Name: ISO 17025 Consultant
Design, implementation and audits of ISO 17025 (Guide 25) quality assurance (QA) program for testing and calibration laboratories.

SOP development, review and evaluation.


Service Name: GLP Consultant
Design, implementation and audits of GLP (Good Laboratory Practices).

SOP development, review and evaluation.


Service Name: Import and Export Consultant
Assisting importers and exporters of products regulated by Health Canada and the FDA to identify all forms they must fill out as well as all accompanying documentation which must be submitted to Customs for clearance / pre-clearance of their shipments.

This also includes registration and pre-clearance of Foods for export to the United States under the new FDA requirements for under their BioTerrorism Protection Act.


Service Name: Quality Control (QC) Consultant
We will help you to determine which quality control (QC) tests are required for your regulated product, and which QC tests are not worth performing. We can also ensure the QC test methods are the most appropriate and have been properly validated. We can also evaluate various commercial QC test labs and prepare a report which compares and contrasts the capabilities of each lab (service, price, turnaround, expertise, etc.)

Service Name: Training - Quality Assurance & Regulatory
ICS has trained over 1,000 people and has presented at a wide variety of conferences.

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


Service Name: HACCP Quality Assurance (QA) Consultant
Hazard Analysis and Critical Control Point:

ICS Inc. can help you to implement a scientific system for process control that has long been used in food production, to prevent problems, by applying controls at points in a food production process, where hazards could be controlled, reduced, or eliminated.

We can help by:

conducting an analysis of biological, chemical & physical hazards;

creating points (or procedures) in a the process which control a hazard by preventing, eliminating, or reducing it to acceptable levels;

establishing monitoring procedures;

establishing corrective actions;

establishing Record Keeping procedures; and

establishing Verification procedures.

Service Name: Environmental Management Consultant (ISO 14000)
Our Environmental Management System (EMS), allows companies to address the environmental impact of their products, services and business practices. ICS Inc. also provides a system for monitoring, controlling, and improving performance regarding any regulations, legislation, and codes of practice that an organization has to comply with.

ICS Inc. can help you to define targets and objectives for meeting and exceeding mandatory & customer requirements. We also focus is on prevention and continuous improvement.

We can help you with:

Establishment of an environmental Mission Statement.

Identification of environmental impacts and legal requirements.

Setting environmental objectives and targets.

Establishing responsibilities, procedures, policies and records.

Creating systems for regular evaluation and improvement of the environmental management system


Service Name: Recruitment of Technical Personnel
Our services related to technical personnel only (i.e.: scientists, engineers, regulatory specialists, quality assurance specialists, technical product staff, etc.)

We can:

Identify the technical & personel requirements for the position
Prepare the advertisement
Identify most appropriate locations for posting the advertisement
screen & short-list all potential candidates
perform the initial interviews
perform reference checks on the candidates.


Service Name: Chemical label consulting
Ensuring labels comply to the Consumer Chemicals and Container Regulations (CCCR).

2. Ensuring all ingredients are already on the Domestic Substances List (DSL), and are allowed in Canada and at the specified concentrations.

3. Determine the Annual Chemical Reporting Requirements for products on the DSL or Challenge list.

4. Making sure all labelling requirements are met, such as languages, net quantities, area and size of inner & outer labels, font size & type, where on the label certain information must be located, etc.

5. Determine what hazard symbols/statements must be on the label by performing assessments for Toxicity, Corrosivity, and Flammability for each route & subcategorizing each assessment (i.e.: harmful vs. toxic; corrosive vs. irritant).

6. Determine which ingredients must be on the label (and which do not).

7. Perform assessment to see if the Child Resistant Container (CRC) requirements apply.

8. Ensuring proper labelling claims (i.e.: acceptable versus unacceptable claims, so one does not make claims inappropriate for the type of product).

9. Identifying any safety issues / label warnings associated with the ingredients, along with the proper format, location, size & presentation of the warnings and its logo.

10. Ensuring proper naming of ingredients, and their correct order.

11. If the product is listed as “biodegradable”, check to see if this claim was evaluated to international standards.

12. Determining if any of the ingredients have to be pre-registered under EAR (Environmental Assessment Regulations) or CEPA (Canadian Environmental Protection Agency).

13. Drafting MS Word versions of the proposed labels in English and forwarding them to the client for review.

14. Forwarding the first batch of reviewed labels to the most appropriate Product Safety Officer of Health Canada’s Consumer Product Safety Bureau (CPSB).

15. Once the English version of the label has been approved by the CPSB, perform the French translations using specific government wording. (Our translator is fluently bilingual and holds a Ph.D. in the natural sciences. Therefore, she should not have any problems translating the various technical terms).


FSC Code: 4610-Water Purification Equipment
4620-Water Distillation Equipment, Marine and Industrial
6505-Drugs, Biologicals, and Official Reagents
6508-Medicated Cosmetics and Toiletries
6510-Surgical Dressing Materials
6515-Medical and Surgical Instruments, Equipment, and Supplies
6520-Dental Instruments, Equipment and Supplies
6540-Ophthalmic Instruments, Equipment, and Supplies
6545-Medical Sets, Kits, and Outfits
6550-In Vitro Diagnostic Substances, Reagents, Test Kits and Sets
6630-Chemical Analysis Instruments
6635-Physical Properties Testing Equipment
6640-Laboratory Equipment and Supplies
6670-Scales and Balances
6680-Liquid and Gas Flow, Liquid Level, and Mechanical Motion Measuring Instruments
6685-Pressure, Temperature, and Humidity Measuring and Controlling Instruments
6910-Training Aids
8510-Perfumes, Toilet Preparations, and Powders
8520-Toilet Soap, Shaving Preparations, and Dentifrices
AJ00-General Science and Technology
AN00-Medical
B000-Chemical/Biological Studies and Analyses
E000-Environmental Services
H100-Quality Control Services
H200-Equipment and Materials Testing
H300-Inspection Services (incl. commercial testing and Laboratory Services, Except Medical/Dental)
H900-Other Quality Control, Testing, and Inspection Services
Q000-Medical Services
R001-Specifications Development Services
R004-Certifications and Accreditations for products and institutions other than Educatonal Institutions
R005-Technical Assistance
R006-Technical Writing Services
R010-Auditing Services
R012-Patent and Trade Mark Services
R014-Operations Research Studies / Quantitative Analysis Studies
R201-Civilian Personnel Recruitment (incl. Services of Employment Agencies)
U004-Scientific and Management Education

Technology Profile

ICS Inc. is a team of Quality Assurance & Regulatory Affairs specialists.
We are a consortium of chemists, biochemists, biologists and microbiologists.
We aid developers, manufacturers, packagers, labellers, testers, marketers and importers / exporters to meet their legal requirements. Our focus is on the pharmaceutical, nutraceutical, cosmeceutical, cosmetic, food, functional food, feed, natural health product (NHP) and medical device industries.
Our services span “from cradle to grave” in the life of a product.
Examples include:
• performing scientific literature searches;
• performing Drug Submissions;
• helping companies to design, implement and audit their QA programmes
(i.e.: GMP, GLP, GCP, HACCP, ISO 17025 and ISO 13485);
• coordinating Clinical Trials;
• performing 3rd –party QA audits of manufacturers and labs on behalf of clients;
• ensuring all ingredients, labels and marketing information are compliant to Health Canada, FDA, etc.; and
• managing the entire spectrum of Regulatory Affairs issues to ensure that all paperwork is submitted to the appropriate health authority in a timely and accurate manner.

Market Profile


Alliances:

Strategic Alliances: Over the years we have developed excellent working relationships with
various foreign regulatory / health authorities such as the United
States FDA, Australian TGA, etc.
If we do not have the internal expertise, we have access to a global
network of regulatory and quality assurance professionals whom we subcontract
on a confidential, case-by-case basis.
Consequently, our client base has now grown to span the globe as a
full-service company.Industry Sector Market Interests:
Geographic Markets: Export Experience:

Sector Information

Plant Information:
Total Plant Size (Areas sq ft):
Office size: 1,500 sq ft

Distribution of Employees
Nelson, BC Office:

ICS Inc. presently have 5 full-time staff - 4 of which have a minimum
of B.Sc., while the other member is a marketing & advertising specialist to the Nutraceutical & Pharmaceutical industries. Each of these staff has at least 15 years of experience in their field of expertise and in management.

Satellite offices in Vancouver, BC, Edmonton, AB and Saskatoon, SK:

ICS Inc. also has 10 part-time Specialists (which have signed Confidentiality Agreements with ICS Inc.). These specialists include: toxicologists, pharmacists, ethnobotonists, chemical & construction engineers, food scientists, loan & grant application agent, etc.).

Unique Applications:
Our focus is assisting small to mid-size companies with their QA and Regulatory requirements.

Where we excel, is communicating dry, technical issues in a straight-forward, non-technical manner which is easily understood and applied.

We are also very proficient and able to apply these dry regulations in a practical manner.

We also conscientiously focus on ensuring the Quality Assurance program does not become a paper nightmare – but is a ‘living/adaptive’ program to ever-changing business dynamics & regulatory environments, and which you can use to train future employees more efficiently. This will ensure meeting not only your company’s immediate needs, but also your future needs.

Due to our ability to provide exceptional services at highly-competitive pricing and our desire to build mutually beneficial long-term relationships with our clients we have continually expanded our range of service & expertise by attracting the best people available.

Key / Major Clients:
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).

Success Stories:
Our services related to technical personnel only (i.e.: scientists, engineers, regulatory specialists, quality assurance specialists, technical product staff, etc.)

We can:

Identify the technical & personel requirements for the position
Prepare the advertisement
Identify most appropriate locations for posting the advertisement
screen & short-list all potential candidates
perform the initial interviews
perform reference checks on the candidates.

We have been successful in linking Canadian manufacturers with foreign marketers (and vice versa).

quely positioned to provide
referrals to pre-qualified service providers
(such as: raw material suppliers, commercial
labs, contract researchers / manufacturers /
processors / packagers / labellers, brokers and
translators).

Contact Information


Dale Enright
Title: President
Telephone: (250) 359-7873
Fax: (250) 359-7874

Michelle Harris
Title: Admin/Exec Assistant
Area of Responsibility: Research/Development/Engineering
Telephone: (250) 359-7873