Same Quality as Clinically Proven
We follow EN-Sure™ certified quality system to assure same efficacy, safety and chemistry of ingredient as clinically proven in each and every supply. This is achieved by controlling the important quality parameters of identity verified biomass, optimized GMP production, validated analytics, and proper documentation. EN-Sure™ certified ingredients ensure that each batch getting formulated delivers the real benefits as proven in human studies.
Authentication – Correct identity verification is the first step of our research program. Only authenticated Non GMO biomass enters the next stage of research and development. Selecting and authenticating the correct biomass with highest quality involves series of test including macroscopic and microscopic evaluation, DNA techniques and identification test using FTNITR, TLC and HPTLC as applicable. This helps in setting the specifications for incoming raw material to guarantee authentic purchase. This also helps in assuring raw material standard for required potency and purity, maturity, absence of adulterants and maintaining consistency in each and every batch.
GMP Production – Enovate-managed quality manufacturing is done using highest standard extractors and processors. Our ingredients are ISO, Vegan and Kosher certified and Halal compliant.
Validated analytics – Each and every batch undergoes testing for actives and impurities using up to date testing protocols and modern analytical tools like HPLC, FTNIR, FTIR, GC-HS, GC-MS HPTLC, LC-MS etc. by highly trained scientific personnel.
Residual solvents are tested to detect traces of solvents upto ppb levels & thus complying limits as per ICH Q3C (R4) guidelines.
Each heavy metal (arsenic, cadmium, lead and mercury) is tested individually by using latest technologies like ICP-OES & ICP-MS. Our brands comply with stringent requirements of California Prop 65 limits.
Enovate Biolife ingredients are safe from pollutants, insecticides, fungicides, herbicides, pesticides, microbes and allergens.
Documentation – Proper documentation is at the heart of GMP. We maintain comprehensive documentation right from raw material to extract. We take pride in supporting our customer in providing all documentation relevant to support quality, safety, efficacy and regulatory compliance in timely manner.