Services We Offer
Our area of expertise revolves around pioneering research and providing affordable remedies to address any issues related to formulation
Formulation Development
GVB expertise team applies the Quality by Design (QbD) technique to develop robust formulations with the help of advanced equipment’s to support the swift development of all dosage forms, from early clinical to commercialization. We aim to minimize product changes during the clinical and marketing phases with a scientific-bridging study design that helps achieve development goals by designing a formulation with appropriate bioavailability, stability, and a robust manufacturing process.”
Analytical Development
We offer analytical services throughout their life cycle, including developing stability-indicating assays, related substances, and residual solvent methods for drugs and products. Each developed method will be validated per the ICH guidelines and the regulated markets. Additionally, GVB helps to establish strong evidence to support the robust formulations by performing uniformity content, dissolution, and microbial testing. Notably, the critical assessment of genotoxic impurities of drug substances and their methods and extractable/leachable study of drug products of all dosage forms are explicitly supported by GVB Life Sciences to select the appropriate excipients in an early stage of formulation and investigate interactions between API and excipients using analytical techniques
We offer forced degradation studies, stability-indicating assays, content uniformity, residual solvents, method validation, and novel analytical methods for formulation screening and optimisation.
We follow cGMP regulations and provide product release services, including assay, dissolution, content uniformity, water content, elemental impurities, residual solvent, and microbial limit testing.
Our stability study services cover ICH and specific conditions, providing strong evidence for the life-cycle stability evaluation of drug products. We also offer API-Excipient-Packaging Release testing services and compatibility studies between packaging components and drug products.
We help our customers select the appropriate excipients in early formulation development and investigate interactions between API and excipients using analytical science.
Pre-Formulation Studies
Our pre-formulation services are designed to provide fundamental information on compounds using small quantities of active pharmaceutical ingredients (APIs) and excipients. By characterizing the critical attributes of the compounds, including particle size, solubility, polymorphism, pKa, Log p/Log D, and inherent dissolution using advanced equipment’s. GVB’s expert team is committed to deliver the accurate and reliable results that will enable our clients to decide on selecting the best compounds for their pharmaceutical applications
Clinical Trial Services
Our organization specializes in managing clinical trials, its supplies, and contract manufacturing services for pharmaceutical companies by helping Phase I-III clinical trials up to product registration with the approval of NDA/ANDA. It is committed to maintaining the industry’s highest quality and compliance standards by providing customized solutions to meet each client’s unique needs.
Technology Transfer
GVB Team for Technology transfer plays a crucial role in pharmaceutical product validation, strategic planning, and ongoing process control with the collaboration between various disciplines which is necessary to ensure successful technology transfer. The GVB team understands the client’s expectations and supports the regulations, procedures, roles, equipment, culture, training, and competencies
