Company Overview

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) and medical device industries.

Company Information

Additional Details

Legal Name: Innovative Consulting Solutions Inc.

Number of Employees: 6

Contacts

Services

• Botanical Consultant

  see our 'Natural Health Product' services

• Clinical Trial Consultant

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

• 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.

• 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.

• Dietary Supplement Consultant

  see 'Natural Health Product' services

• 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

• 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

• Functional Food Consultant

  see Food Consultant services

  see Natural Health Product Consultant services

• 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:

  • 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.
  • Identify the various municipal, provincial, federal and private funding programs which may be available to your company.
  • Assist with the technical aspects of the various grant and subsidy applications
  • Estimate percentages for potential of success on each grant or subsidy application.
  • Estimate monetary values of each successful application.
  • Be the Technical Liaison with the Grant application personnel, on your behalf.
• Glp Consultant

  Design, implementation and audits of GLP (Good Laboratory Practices).

  SOP development, review and evaluation.

• 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.

• Herbal Consultant

  see our 'Natural Health Product' services

• 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.

• Iso 13485 Consultant

  see our 'Medical Device Consultant' services

• 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.

• 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:

  • Ensuring the label information exactly matches the product registration documentation;
  • Ingredients are listed in the correct order and using the proper terminology;
  • 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;
  • 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);
  • Appropriate directions for use;
  • How to correctly include all of the legally required Risk Information (cautions, warnings, contraindications or known adverse reactions);
  • Correct units for each ingredient (mg, mcg, IU, mL, etc.) and/or correct dosage instructions;
  • Determining which marketing / advertising claims are allowed and which ones are not (as well as the specific wording which is allowable);
  • 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);
  • Correct font sizes for each heading on the label;
  • Which headings and/or statements must be in bold;
  • Ensuring the proper format & location for the expiry date and lot number;
  • Which terms or phrases must be bilingual and which ones are optional;
  • If requested, perform all legally required French translations.
• 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.

• 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)

• 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.

• Nutraceutical Regulatory Consultant

  see Natural Health Product services

• Nutritional Supplement Consultant

  see 'Natural Health Product' services

• 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)

• Quality Assurance (qa) Consultant
• 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.)

• 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.

• 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.

• 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.

• 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.

• 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

NAICS Categories

• 311119 Other Animal Food Manufacturing
• 325410 Pharmaceutical and Medicine Manufacturing
• 334512 Measuring, Medical and Controlling Devices Manufacturing
• 541690 Other Scientific and Technical Consulting Services

Additional Information