Olcay’s End-to-End Regulatory Affairs consultancy services
1. Dossier/submission preparation or review and filing.
2. Development of regulatory strategy for the product’s life cycle.
3. Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and submission approval process.
4. Regulatory classification of products across different jurisdictions.
5. Provide expert regulatory CMC compliance advice throughout development.
6. Work with Sponsors and regulatory authorities through the resolution of complex development issues.
7.Scientific and medical writing services.
8. Regulatory electronic submission publishing services
Our team Olcay carries 20+ years of experience brings consulting and solutions under the same roof.
Our service philosophy is proactive, not reactive. We are available to cater to you 24x7.
Our team is subject matter expert. We ensure delivery of excellence from planning to delivery.
We will handle every detail and coordinate all stakeholders so you can rest assured for delivery.
Facilitate interaction with regulatory agencies, such as in meetings and conference. Calls, negotiations during development stages, submissions and submission approval process
Yes, we help our partners to design and automate all regulatory reports so that our partners never fail to meet compliance.
Yes, we do you provide regulatory strategy for the product’s life cycle.
Blog Electronic submissions for IND Safety Reports to FAERS Key Highlights Starting June 28, 2021,...
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We trust Olcay for on time delivery and out of box support.
Olcay have been proven partner for all our pharma needs.
Olcay is our technology partner for regulatory reports.