INDEPENDENT BY DESIGN
Laboratory strategy without laboratory bias.
Kompete does not own a laboratory, and that is deliberate. We select the testing site that fits the matrix, the method, and the regulator, rather than the one that fits an internal utilization target. Our network spans accredited contract laboratories across North America and Europe covering chromatography, spectroscopy, microbiology, elemental analysis, and bioanalytical work. You get method selection driven by the analyte and the claim, competitive quoting across qualified sites, and a single point of technical accountability for the entire program.
PILLAR 01
Confirm potency and characterization
Establish that every declared active is present at the labelled amount, in the form you claim, from the source you claim.
Active ingredient assay and label claim verification
Nutritional analysis and full supplement facts panel data
Physical property testing including particle size, bulk and tapped density, moisture, water activity, pH, specific gravity, viscosity and colour
Botanical species identification by HPTLC, DNA barcoding and microscopic examination
Characterization of extracts, marker compounds and standardized fractions
Blend uniformity and content uniformity across the batch
PILLAR 02
Verify purity and stability
Contaminant control and shelf life evidence are where most files fail. Both are built from protocols written before the first sample is pulled.
Real time and accelerated stability testing under ICH conditions
Microbial limits, absence of specified pathogens and objectionable organism screening
Heavy metals including arsenic, cadmium, lead and mercury
Pesticide and herbicide residue panels
Radionuclide screening and residual solvent testing
Oxidative stability for lipids and oils including peroxide value, anisidine value and TOTOX
Allergen testing and cross contact verification
Impurity profiling and degradation product identification
PILLAR 03
Achieve market certifications
Certification marks are earned through documentation as much as through testing. We prepare the file, close the gaps, and manage the reviewer relationship.
NSF/ANSI 173 dietary supplement certification
NSF Certified for Sport and equivalent banned substance programs
Third party quality marks, non GMO, organic and allergen free positioning
Facility and supplier qualification support
Ongoing surveillance testing and annual audit readiness
PILLAR 04
Support development and clinical work
When a product moves toward clinical evaluation or a pharmaceutical pathway, the analytical requirements change. We scale the program with it.
Analytical method development, qualification and validation to ICH Q2
Quality control release testing and certificate of analysis review
Formulation validation and compatibility testing
Bioanalytical method support for pharmacokinetic and bioavailability studies
Dissolution and disintegration profiling across dosage forms
THIRD PARTY CERTIFICATION
What certification actually verifies.
NSF/ANSI 173 is the American National Standard that sets requirements for ingredients used in dietary and nutritional supplements. Certification under that standard rests on three reviews. The first confirms that the contents of the container match the declared label. The second is a toxicological assessment of every intentionally added ingredient at the level used. The third screens for undeclared ingredients and for contaminants above acceptable limits.
Products intended for competitive athletes are held to an additional layer. NSF Certified for Sport evaluates finished product against a screening panel covering more than 280 substances prohibited by major sport governing bodies, including stimulants, anabolic agents, narcotics, diuretics, beta-2 agonists and masking agents. The program is recognized by the NFL and NFL Players Association, MLB and MLB Players Association, the PGA and LPGA, and the Canadian Centre for Ethics in Sport.
The distinction that matters commercially is ongoing verification. A credible program does not accept manufacturer generated data or clear a product on the strength of a single retained sample. It tests finished product in its own accredited laboratories, audits the manufacturing site on a defined cycle, and retests certified products periodically to confirm continued conformance. That is the difference between a mark that protects an athlete and a logo that decorates a panel.
Kompete prepares brands for that level of scrutiny before the application is filed. We review the formula for prohibited and at risk ingredients, assess raw material suppliers and certificates of analysis, close specification and documentation gaps, and coordinate the submission through to award.
Certification is earned in the facility before it is confirmed in the laboratory.
QUALITY SYSTEMS
The paperwork that carries the science.
Testing produces numbers. Compliance requires the framework that explains why those numbers are the right ones. Kompete builds and maintains that framework alongside your internal team.
FINISHED PRODUCT SPECIFICATIONS
Product specific FPS documents built to Health Canada expectations, including identity, potency, purity, physical and microbial limits with justified acceptance criteria and named test methods. This is a core requirement of the NPN application and a frequent source of information requests.
STANDARD OPERATING PROCEDURES
Development and revision of SOPs that make workflow execution consistent, compliant and auditable, written for the people who will actually follow them.
PROTOCOLS AND TECHNICAL REPORTS
Stability protocols, validation protocols, testing reports, technical justifications and risk assessments prepared to survive third party review.
INVESTIGATIONS
Structured investigation of out of specification and out of trend results, adverse stability trends, customer complaints and post change performance, with root cause analysis and corrective action.
CHANGE CONTROL SUPPORT
Assessment of formulation, supplier, process, site and packaging changes, including which changes require new stability data and which require regulatory notification.
AUDIT READINESS
Internal quality audits, gap assessments against cGMP expectations, and preparation for customer, certification body and regulator inspections.
CROSS FUNCTIONAL PROGRAM MANAGEMENT
Direct participation in project teams with clear, timely status reporting so quality work does not become the item that delays launch.
R&D SUPPORT
From bench top to first commercial batch.
Early stage data decides how much rework happens later. Kompete produces and evaluates bench top and pilot scale samples to support formulation development, experimental development activity and product testing before capital is committed to a full production run. That includes preliminary stability studies on R&D samples, with protocol creation, test setup, ongoing monitoring, data collection and interpretation, so that formulation decisions are made against evidence rather than assumption. Where the work qualifies, the resulting documentation also supports experimental development and technology advancement claims.
PRACTICAL REFERENCE
What your product will typically need.
Test panels vary by matrix and market. The table below reflects the panels we most often specify for finished product release.
Dosage form
Core release panel
Common additions
Powders and sticks
Assay, identity, moisture, water activity, blend uniformity, microbial limits, heavy metals
Flow and density, dissolution profile of actives, sweetener and flavour stability
Capsules and tablets
Assay, identity, weight variation, content uniformity, disintegration, microbial limits, heavy metals
Dissolution, hardness and friability, residual solvents on extracts
Softgels and oils
Assay, peroxide value, anisidine value, TOTOX, fill weight, microbial limits, heavy metals
Fatty acid profile, oxidative stability under accelerated conditions, shell integrity
Liquids and shots
Assay, pH, specific gravity, appearance, microbial limits including yeast and mould, heavy metals
Preservative effectiveness testing, brix, sedimentation and phase stability
Gummies and chews
Assay, water activity, texture and hardness, microbial limits, heavy metals
Sugar and polyol profile, colour stability, sticking and cold flow under accelerated conditions
Topicals and cosmetics
Assay of actives, pH, viscosity, microbial limits, heavy metals
Preservative challenge testing to ISO 11930, stability under freeze thaw and light exposure
ENGAGEMENT MODEL
Four steps from question to defensible file.
01
Scope
We review the formula, the dosage form, the intended markets and the claims, then define which tests are required, which are commercially useful and which add cost without adding value.
02
Specify
We write the specification, the methods and the protocols, and qualify the laboratories that will run them.
03
Execute
We manage sample submission, timelines and laboratory communication, and review every result as it arrives rather than at the end.
04
Defend
We deliver the reports, specifications and justifications in the form your regulator, certification body or retail customer expects, and we stand behind the interpretation.
Bring us the formula. We will tell you what it needs to prove.
Whether you are assigning a first shelf life, responding to an information request, preparing for certification, or rebuilding a specification that no longer matches the product, the starting point is the same conversation.