Regulatory Science & Product Development Experts helping customers
Commercialise Products | Reduce Time to Market | Achieve Compliance | Grow Business
Risk & Compliance
In regulated industries, non-compliance to regulations is an expense that no company can afford and hence a majority of C-level executives, across the world, consider regulatory risks and compliance to pose maximum threat to a company’s business operations.
Vyomus provides QA/cGXP consulting services such as setting up Quality Systems, conducting independent Medical Device QMS, GCP, GCDMP, GPvP audits, study, process and quality documents review along with support for pre-approval inspections (PAI). Our experienced regulatory consultants can help you ensure regulatory compliance during the complete product commercialisation lifecycle of a medicine or medical device.
We provide end-to-end risk and compliance services which will help you identify emerging risks, understand interdependencies between risks, visualize aggregate risk exposure across the organization and understand possible opportunities. This will ultimately help you strategise and implement acceptable quality systems for R & D, drug development, clinical trial supplies, commercial supply etc., leading to effective risk management and pre-emptive compliance.
Vyomus Consulting has developed customizable methodology which integrates science, regulations and business objectives to helps its experienced team of regulatory and quality professionals analyze, design and implement business and quality processes which neutralizes risk and ensure regulatory compliance in a rapidly changing regulatory environment.
Our experts are well versed in pharmaceutical, medical device and diagnostic regulations, including GLP, GCP, GCDMP, GPvP, GMP etc., and offer time-tested solutions for companies of all sizes. We will help you develop practical, tailored quality systems covering the entire product lifecycle, which includes strategy and implementations of all processes from product development and manufacture through to packaging, labelling and distribution.
Industry focus : Pharmaceuticals, Medical Devices& IVDs.
The team at Vyomus is flexible to fit your needs. We can provide selected or comprehensive services as required to meet your specific program needs. We could provide any one or all of the following services : Due Diligence, Gap Analysis, SOP Writing, Review, Development, Quality Management Documents Review, Development, Quality Management System Review, Development, Sponsor Side audits of Quality systems at CRO, IT Supplier, Service Provider, Clinical and Preclinical Sites etc.,
| Independent Audits | Quality Management Systems |
Vendor Qualification |
|---|---|---|
| Study Audits, Project Audits, Facility, Vendor, Process Audits. |
Creation & Management. Standard Operating Procedures preparation, review, maintenance. GCP, GCDMP; GPVP; In-house Standards. |
Due diligence, Selection, Gap Analysis, Sponsor Side audits of Quality systems. |
