Regulatory Services

Regulatory & Compliance

Regulatory Services

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

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Service Segments

Review and filing

Dossier/submission preparation, review & filing

Operations

Disaster Recover Management & Testing.

compliance advice

CMC compliance advice throughout development.

Regulatory Strategy

Regulatory Strategy for the product’s life cycle

Submissions

End to end vendor onboarding and management.

medical writing

Scientific and medical writing services

Send us questions.



    Benefits of Regulatory Services

    Cost savings

    Leverage our expertise for regulatory and experience cost effective services.

    Accurate

    Quality-first approach and close attention to detail make Olcay Market Leader.

    Flexibility

    Range of offerings enable you to choose solutions meet your needs and budget.

    Management

    We manage your process efficiently and ensure deadlines and deliverables.

    Why you should choose us.

    20+ Years Experience

    Our team Olcay carries 20+ years of experience brings consulting and solutions under the same roof.

    We are Proactive

    Our service philosophy is proactive, not reactive. We are available to cater to you 24x7.

    We Deliver Excellence

    Our team is subject matter expert. We ensure delivery of excellence from planning to delivery.

    Project Management

    We will handle every detail and coordinate all stakeholders so you can rest assured for delivery.

    Frequently asked questions

    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.

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    TESTIMONIALS

    Customers Voice

    We trust Olcay for on time delivery and out of box support. 

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    Siara Miller Found & President

      Olcay have been proven partner for all our pharma needs.

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      John Doe VP Technology

        Olcay is our technology partner for regulatory reports.

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        Eva Spice Head - Operations