For development of Therapeutics, Devices & Diagnostics

Regulatory Reporting

Knowledge, Expertise, Mature Process @ Work for you….. To Deliver your Projects on Time and Within Budgets

Dependable Quality, Timeliness, Responsiveness and Reliability ….. to turn clinical data into safety information

At Vyomus Consulting, our team of knowledgeable drug safety professionals offer expert consulting and provide optimal solutions throughout the clinical development cycle – during different phases of Clinical Trials and Post-Marketing phase. We design and implement pharmacovigilance projects specifically tailored to your organization’s requirement in terms of budget and timelines.

We also have the capability to function as a “non-competing tactical satellite” or as a “non-competing extension” or division of each sponsor’s business. Critical safety functions can remain in-house under direct supervision of the sponsor, while process-driven aspects can be outsourced to expedite processing, reconciliation, reporting and query resolution. Rest assured, the quality of delivery would be accepted by International regulatory authorities.

We use a blend of proven operational methodologies, processes, Standard operating procedures (SOP’s), technology, infrastructure, tools, templates and the ‘right’ kind of human intellect to deliver our projects consistently on time and agreed upon quality guidelines to generate significant ROI. The final goal being Affordable, Consistent, high-quality data (Source-verified, Accurate, Accessible, Reproducible) without compromising your timeline or budget. Vyomus Consulting offers the following services in this area…..

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We manage, develop and implement distinctive and compelling implementation strategies to deliver effective projects by working hand in hand with operational teams, customer standard operating procedures and organisations involved in drug discovery and development.

Our services can begin early in development by creating organisation / study / function specific SOP’s, continue through writing therapeutic, phase and study specific protocols and authoring reports. Post-marketing writing services include PSUR writing, regulatory report writing, country specific export / import regulatory dossier preparation.

The team at Vyomus Consulting is flexible to fit your needs. We can provide selected or comprehensive services either from our facility or onsite at your facility as required to meet your specific program needs.

Discuss Your Needs

Thank you for your interest in Vyomus Consulting. To conact us, please complete the form below or send us email at info@vyomusconsulting.com

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