Formula Development Solutions for Canadian Regulatory

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

Importance of Formula Development

Formula Development solution lets you match medicinal and active ingredients with desired health claims. It is a key area of the product design process where the active ingredient  is combined with other substances and maximizes 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. 

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

Formula Development Solutions at Quality Smart Solutions

We understand that customized Formula is required depending on your requirements (speed to market or 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 and 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 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.

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