Regulatory Science & Product Development Experts helping customers
Commercialise Products | Reduce Time to Market | Achieve Compliance | Grow Business
Independent Auditing Services
At Vyomus Consulting, our quality management teams include experienced regulatory, industry process and quality experts who help deliver best-in-class quality systems by applying the latest regulations (GLP, GCP, GCDMP, GPvP), process optimization techniques, and technology tools with a focus on external customers as well as internal people (customer) teams.
Vyomus Consulting approaches each organization with a passion to understand the company’s current and emerging business, regulatory risks and opportunities. Our goal is to help customers address their most pressing regulatory needs immediately, with an understanding of the broader regulatory and business context for the future. To serve each customer, we work with a team of professionals who can offer the right combination of experience in the pharmaceuticals and life sciences sector and technical knowledge in the relevant areas.
We believe our role as consultants is not to simply find faults but to enhance your business. We develop and implement strategies and recommendations that not only resolve and embrace all relevant compliance issues, but also work with your business model and allow you to advance your efforts with minimal interruption.
Perhaps your organisation needs clarification on local regulatory issues or someone knowledgeable to review pre-submissions. Or you have identified a short-term project where an experienced local expert is needed. Or maybe your organisation needs an unbiased review of existing policies and procedures. Bringing in the right consultant can be a cost effective way to add value to your business. Our team of experts can identify how best to overcome existing challenges and move towards rewarding results.
- Independent audits of : Quality System (ISO, GCP, GLP, GMP, GCDMP; GPVP), Facility, Process, Project, Program, Risk Management Plan; Product Development Plans etc.,
- Study Audits – Clinical studies (Phase 1 to 4), Preclinical studies, Bioavailability & Bioequivalence studies, Formulation development etc.,
- Vendor selection and qualification – Clinical Research Organisations, Bioavailability & Bioequivalence centers, Contract Manufacturing Organisations, Preclinical study vendors, Clinical Data Management vendors, Formulation development vendors.