For development of Therapeutics, Devices & Diagnostics

Risk & Compliance

Managing Regulatory Risk & Compliance towards rapid product Commercialisation !

In the pharmaceutical and life sciences industry, a majority of C-level executives, across the world, consider regulatory risks and compliance to pose maximum threat to a company’s business operations and hence spend the most time on activities aimed at controlling regulatory risk and compliance.

Quality Risk Management and Compliance is an integral part of current good practices (cGXP) in the pharmaceutical and life sciences industry and has been included as a key element by global regulators to ensure availability of safe and effective medicines. Hence, non-compliance to quality is an expense that no company can afford, since risk to quality is directly based on scientific knowledge and linked to protection of the patient.

Vyomus Consulting has developed a customizable methodology which helps its experienced team of regulatory investigators and quality professionals to 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 biopharmaceutical, 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.

By explaining the requirements of regulators we help you strategies and implement acceptable quality systems for R & D, drug development, clinical trial supplies, commercial supply etc., to ensure effective risk management and preemptive compliance leading to a rapid, product commercialisation.

Vyomus provides end-to-end risk and compliance services by helping you identify emerging risks, understand interdependencies between risks, visualize aggregate risk exposure across entire organization, apply up-to-date risk information, understand possible opportunities, which will ultimately lead strategy development, management decision-making and implementation of the approved risk and compliance mitigation strategy.

Our services include the following :

Independent Audits Quality Management Systems Certifications Vendor Management
Facility, Vendor, Process, Project, Program, Study Audits. ISO, GCP, GLP, GMP, GCDMP; GPVP; In-house Standards. ISO, CE, GCP, GLP, GMP. Identification, Due diligence, Selection, Management.
Risk Management Plan; Product Development Plans, Process Optimisation; Reengineering. Creation & Management. Standard Operating Procedures – preparation, review, maintenance. Biologicals, Biosimilars, Pharmaceuticals, Medical Devices, Diagnostics, Cosmetics, Food Products Project Management, Study Management

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.,

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