Simplify, Regulate & Approve
Seamlessly meet global regulatory requirements to ensure success at every stage.
Regulatory Affairs.
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.
Our Services.
Our services are delivered by a dedicated team of publishing/submission experts supported by senior regulatory leaders.
Writing/Review/Filing of Submissions ( CTD/ACTD and Semi-Regulated Countries)
Product Monograph and Mock-up development as per Plain Language Labelling (PLL), SmPC writing
Risk Management Plans (RMPs)
Drug Master Files
eCTD Publishing
eCTD Submission
eCTD Lifecycle submission management
Framework Diffrence.
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Short Timelines delivered by efficient teamwork
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Strong relationships with regulators enable rapid troubleshooting
High level of client satisfaction -
Responsive & direct contact with experienced senior leaders
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Scientifically qualified regulatory professionals deliver your work
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Custom-made processes to suit your needs and organization
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We anticipate difficulties and find early solutions
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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Proven Track Record.
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24×7 Operations with submissions to GCC, FDA, EMA and other health authorities around the Globe
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100+ life Science Companies Served over last 10 years
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Over 4,00+ Submissions submitted
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100% eCTD technical Approval
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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