Services
Regulatory Services
We collaborate with highly recognized and reputable Contract Research Organization (CRO’s) that are approved by the local regulatory authority (DCGI) as well as other global regulatory bodies.
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Dossier
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Drug Master File
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Bioequivalence (BE) Study, Clinical & Non Clinical Studies, Technology Transfer.
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Sugam Account Opening, NSWS Portal Opening, Test Licenses (CT-10, CT-13, CT-16), Import Registration, Export NOC, FSSAI & much more.
Technology
Technology Transfer
Technology transfer refers to the process of transferring scientific findings, innovations, or technologies from research and development into practical applications. This includes transferring knowledge regarding manufacturing processes, formulations, or laboratory techniques, ensuring that the technology is efficiently applied for large-scale production or regulatory approval.
Product Technology Transfer
We facilitate the transfer of product-related technologies, including formulation, manufacturing processes, and analytical methods. This ensures that the product can be consistently produced at the required quality standards at new manufacturing sites, or during scaling-up production. We manage the end-to-end process from R&D to commercial production, ensuring smooth integration into your existing infrastructure.
Industry Technology Transfer
Our services extend to industry-specific technology transfers, including the adoption and transfer of cutting-edge technologies across various sectors. This includes the implementation of manufacturing processes, compliance with regulatory requirements, and alignment with industry standards to enable seamless integration and scalability. We help clients adopt best practices and adapt innovative technologies to meet industry-specific challenges.
Studies
Clinical & Non Clinical Studies
- Clinical Studies: Clinical studies are research investigations conducted on human volunteers to evaluate the safety, efficacy, and potential side effects of a medical product, such as drugs, medical devices, or treatments.
- Non Clinical Studies: Non Clinical studies are preclinical investigations conducted on laboratory animals or using in-vitro (test tube) methods to assess the safety, efficacy, and mechanism of action of a medical product before it is tested on humans. These studies are essential for identifying potential risks, such as toxicity, that might affect human trials.
BE Study: A Bioequivalence (BE) Study is a type of clinical study that compares the rate and extent of absorption of a generic drug to that of a reference (innovator) drug under similar conditions.
“We collaborate with highly recognized and reputable contract research organization (CRO’s) that are approved by the local regulatory authority (DCGI) as well as other global regulatory bodies”.
Our Global Presence
