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Vendor Selection & Qualification
In most cases, operational challenges of non-availability of internal resources, capacity and or expertise, are overcome by identifying, qualifying and selectingspecialised vendors who are capable of delivering the required business outcomes.
Vendor identification, qualification and selection is a complex and time consuming processwhich is very critical to ensure minimum business risk for the organisation. Properly implemented, it can save the organisation/customer money, loss of reputation from failure to provide core services in a quality manner, and regulatory headaches. With increased outsourcing and heightened regulatory concern, organisations have to carefully manage their relationships with vendors of all shapes and sizes. The ability of an organisation to effectively select and manage vendors is directly related to its safety and soundness.
Vyomus Consulting’s years of service experience in the regulated industry, across a diverse range of product development projects, has reinforced the experience that supplier/vendor selection, audit, qualification, contract negotiation, and oversight are critical to a successful product commercialisation program.
Vyomus Consulting leverages its experience in helping clients locate, evaluate, qualify and select these important resources. Once selected, we routinely serve as the customer’s contact for regulators, clinical research organizations (CROs), contract manufacturing organizations (CMOs), active pharmaceutical ingredient (API) & component suppliers, clinical and non-clinical laboratories. We maintain relationships with such third party organizations to ensure their adherence to sponsor protocols, schedules, budgets, GCPs, GLPs, and GMPs as applicable.
Our experienced, senior regulatory professionals provide vendor identification, qualification and selectionexpertise through all stages of the product commercialisation lifecycle to enhance regulatory submission preparation and achieve faster regulatory, business outcomes, leading to enhanced access to Markets and Opportunities.
Integrating Science, Regulations, Measurable Business outcomes and combining local knowledge with global standards, we move beyond providing expert advice to get your project off the ground, move at a fast pace and achieve faster approvals.
Our overall experience includes over six hundred preclinical, clinical trial approvals, product registrations, marketing authorizations, import and marketing authorizations, manufacturing and marketing authorization and transactions covering a large number of therapeutic and product categories.
Identification, Qualification and Selection of Clinical Research Organisations, Bioavailability & Bioequivalence centers, Contract Manufacturing Organisations, Preclinical study vendors, Clinical Data Management vendors, Formulation development vendors etc.,