Seamlessly Navigating Global Regulatory Landscapes
OmniBioPro offers comprehensive regulatory support tailored to meet international standards at every stage of development, from early research to post-market activities. With deep expertise in regulatory compliance, we ensure your submissions and operations align with the latest global requirements.
Our Expertise Includes
- Submission Preparation: Authoring and managing IND, BLA, MAA, and other regulatory submissions for global markets.
- CMC Documentation: Writing and reviewing CMC sections, including technical summaries for preclinical and clinical submissions.
- Investigator Brochure (IB): Preparing, authoring, and reviewing technical content for regulatory filings.
- Regulatory Strategy Development: Crafting rollouts for market expansion in the U.S., EU, MENA, and other regions.
- Addressing Regulatory Queries: Responding to questions and requests from regulatory authorities with technical precision.
- Post-Approval Compliance: Managing variations, renewals, and maintaining GxP-compliant quality systems.
- Multilingual Document Support: Providing translations of regulatory documents in English, Arabic, Turkish, Hindi, and other languages to meet regional requirements.
