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Simplify, Regulate & Approve.

Seamlessly meet global regulatory requirement

.to ensure success at every stage

Regulatory Affairs.

Smarter regulatory operations start here.

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Cut submission time, reduce errors, and stay ahead of global requirements. All in one platform.

 

We offer Regulatory Affairs services for prescription and non-prescription pharmaceuticals and biologics, medical devices, combination products, natural health products, and cosmetics. The Regulatory Team includes members skilled in clinical/non-clinical, chemistry manufacturing and control (CMC), risk management, and labelling.

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Include: eCTD/ CTD/ ACTD/ Semi regulated Countries 

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SERVICES
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Pharma Covigilance.

PV is defined as a set of scientific activities related to detecting, assessing, understanding, and preventing adverse effects and any other drug-related problems. Following is a figurative explanation of how PV works and the process therein.
 

Some of the key PV activities that helped in maintaining the safety, quality, and efficacy of the said products in the pandemic are as follows:

  • Adopting a good risk management plan

  • Risk assessment with the help of Periodic Safety Update Reports (PSURs)

  • Collation of the exposure data

  • Post-authorization Safety Studies (PASS)

  • Spontaneous reporting of suspected adverse reactions

  • Effective signal management

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Include: PSMF/ PSUR / Rism Mangment System / 

Our Team.

Since our inception, Zenith Consultancy team has been totally focused on building a strategic, quality search practice.
Our team is expert in eCTD file preparation for GCC- Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates.
Giving strategic and technical advice at the highest level. More than 10 experts are associated with us.
             
                       100% eCTD Technical Approval
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Framework  Diffrence.

  • Short Timelines delivered by efficient teamwork

  • Strong relationships with regulators enable rapid troubleshooting
    High level of client satisfaction

  • Responsive & direct contact with experienced senior leaders

  • Scientifically qualified regulatory professionals deliver your work

  • Custom-made processes to suit your needs and organization

  • We anticipate difficulties and find early solutions

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ARTICLES
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Proven Track Record.

  • 24×7 Operations with submissions to GCC, FDA, EMA and other health authorities around the Globe

  • 100+ life Science Companies Served over last 10 years

  • Over 4,00+ Submissions submitted

  • 100% eCTD technical Approval

  • Well-defined processes to continually improve consistency, efficiency, quality control and risk mitigation

Need more details? Contact us.

We are here to assist. Contact us by phone, email, or via our social media channels. 

 

Call Us

Tel: +353 894544055 (Ireland)

Tel: +91-8950072720 (India)

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Mail ID: info@regulatoryaffairs.in

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