Formula Development Solutions for Canadian Regulatory

We have extensive experience with regulatory formula development  to develop various dosage forms based on pre-cleared information and published studies to meet Canadian regulatory requirements and your business goals.

Importance of Formula Development

Our formula development solution lets you match medicinal/active ingredients with desired health claims. Formula development is a key area of the product design process, where the active ingredient is combined with other substances to maximize the therapeutic potential, stability, safety and final health product. Moreover, formula development may determine intellectual property opportunities, which adds to the value of your product.

Our formula development solution helps you avoid regulatory errors or incompatibilities. Companies are more frequently asking for assistance with formula development to create an efficacious, safe and market targeted product so they meet their product launch goals.

NHP Formula Development Plan

Formula Development Solutions at Quality Smart Solutions

We understand that a customized formula is required depending on your requirements (speed to market, targeted health claims based on ingredients). This is why we work closely with clients to gain a complete understanding of their desired health claims and ingredient matrix to then develop a formula within a regulated environment, which visually highlights any ingredient change that does not comply with Health Canada regulations.

Our regulatory product developers have extensive experience in Natural Health Products and Foods, and in developing various dosage forms from capsules to bars to powders. Partner with us to reduce timelines, gain expertise and provide extra assurance you will comply with Health Canada’s rules. Formulas that we develop for you are fully owned by you! Let us develop your formulas and be an integral part of your product’s success story!

Formula Development Strategies

Pre-formulation Studies

Pre-formulation studies include drug substance, API characterization, drug excipient compatibility, container closure compatibility, stress stability, analytical method development, de-formulation studies and dosage form enabling studies.

NCE & Generic Formulations

Formulation development solutions are focused on NCE (New Chemical Entity) and generic formulations to fulfil Health Canada regulations and requirements of target markets to achieve quality attributes and performance metrics set by clients.

Dosage Form Development

We safeguard your business by identifying risk of breaching compliance. Our professionals determine which compliance regulations apply to your industry and implement them successfully.

Overcoming Challenges

We hold expertise in overcoming the challenges (such as flowability, wettability, solubility, dissolution, degradation, bioavailability issues) encountered during the formula development process.

Frequently Asked Questions - Formula Development Solutions

Natural product formulations are a mixture of natural ingredients (medicinal and non-medicinal) that has been designed to do something useful for the human body. It is formed by mixing together several different substances in carefully measured quantities to ensure the product has the required properties and functions.

Formula development is an important aspect of the product design process.  An active ingredient is combined with other substances during this process to maximize the therapeutic potential, stability, safety, and final health product.  Formula development can also determine the intellectual property opportunities that add value to your products.

Our solution makes matching medicinal/active ingredients easy with desired health claims.  This will help you avoid regulatory errors and incompatibilities.  Companies are more likely to ask for assistance in this area to help develop a safe and market-targeted product to meet their product launch goals. 

  1. Pre-formulation studies: These studies include API characterization, drug excipient compatibility, container closure compatibility, stress stability, analytical method development, de-formulation studies, and dosage enabling studies. 
  2. NCE & Generic Formulations: These strategies are focused on NCE (New Chemical Entity) and generic formulations to fulfill Health Canada regulations and requirements of target markets.
  3. Dosage Form Development: Your business will be safeguarded to identify the risks to your compliance and which regulations to apply.

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