Demos Global Group is delighted to announce its opening of commercial operations in the regulatory professional services for the Canadian market.
Demos Global Group is an officially FDA accredited entity under the third-party accreditation program for the FDA-USA, with over 33 years of successful experience in the US market and main offices in Miami, Florida; Madrid, Spain; and Milan, Italy.
Under the umbrella of its successful professional development during all these years, it had decided to begin operations for the Canadian market and assist all its clients to enter such an interesting and profitable market as Canada.
These are some of the professional regulatory services to be offered
FOOD AND BEVERAGE
- Label or Advertisement Compliance Review.
- Label Copy Development.
- Label and Regulation Compliance Auditing.
- Label Redesign Planning to Meet New Regulations.
- Product and Nutrition Claim Compliance Assurance.
- Food and Product Safety Compliance Advice.
- Product and Nutrition Claim Marketing Advice.
- Nutrition Facts Nutrient Calculation Development.
- Government Applications: Temporary Marketing Approvals, Supplemented Food Application; Packaging Reviews.
- Classification and confirmation of food status (e.g., food vs drug or natural health product; conventional food vs novel food).
- Food label reviews for compliance of health and nutrition claims.
- Preparation of Novel Food Notifications.
- Preparation of Food Additives Submissions.
- Interim and Temporary Market Authorization (TMA) applications.
- Designing of Post-Marketing Research Protocols (for TMAs).
- Verification of compliance of health and nutrition claims.
- Arranging pre-submission meetings with the Food Directorate.
- Pre-submission meetings with Health Canada’s Food Directorate.
- Food Packaging Material Registration.
- HACCP Consulting Food Health Claim Substantiation Assessment and Product Development.
- Food Clinical Trials.
- GMO Certification and Organic Certification.
- Preparing for the Safe Food for Canadians Act (SFCA).
- Food Defense/Food Fraud Program and Plan Development.
- CFIA Federal Establishment Registration.
- Food Labelling, Health Claims and Nutrition Facts Table (NFT).
- Novel Food Notifications and Food Additive Submissions.
- Infant Foods and Infant Formula Registration.
- Food Packaging
COSMETICS
- Product Classification & Confirmation.
- Ingredient Listings.
- Ingredient Restriction & Limitation Assessment.
- Required Warnings.
- Formula Review and Development.
- Ingredient Safety Review/Assessment.
- Compliant Advertising Strategies.
- Cosmetic Testing Recommendations for Specific Claims.
- Reviewing Scientific Studies to Substantiate Product Claims.
- Requirements and Validation for Targeted Product Claims.
- Review of Existing Labels, and Compliant Labelling Strategies.
- Dual Canada-US Cosmetic Label Development.
- Providing Guidance on Compliance Issues (GMPs).
- Cosmetic Testing: Compliance/Specification Development.
- Stability Protocol Development.
- Cosmetic Notification Form (CNF) Preparation and Submissions (Canada).
- WERCs System – Review and Guidance for Submissions.
- Cosmetic Notification Form (CNF) Preparation and Submissions (Canada).
- Warning Letter Mitigation.
MEDICAL DEVICE SERVICES FOR CANADA
- Regulatory strategic planning and product classification.
- Organize and manage meeting(s) with the Therapeutic Products Directorate (TPD).
- Prepare and file CTA’s (Clinical Trial Applications).
- Prepare and file Class II, III and IV applications.
- Provide application support during TPD review.
- Perform Quality System
- Provide label and advertising review.
- Resolve regulatory compliance