Regulatory Affairs
Regulatory Affairs
At Weltrix, our Regulatory Affairs services within the Contract Research Organization (CRO) framework are designed to expertly guide your pharmaceutical, biologic, or medical device product through the complex global regulatory landscape. We understand that successfully navigating regulatory requirements is critical to accelerating your product's journey from development through clinical trials to market approval.
What We Offer
Regulatory Strategy Development: We collaborate closely with you to define clear, product-centric regulatory pathways that align with your timelines and budgets. Our strategic planning covers all stages from preclinical to post-marketing activities.
Regulatory Submission and Approvals: Our team manages the preparation, submission, and follow-up of regulatory filings such as Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), and safety reports like DSUR and PSUR. We ensure compliance with the policies of regulatory bodies across multiple territories worldwide.
Electronic Documentation Management: We streamline the creation, publishing, and submission of the electronic Common Technical Document (eCTD), a mandatory format for regulatory submissions.
Lifecycle Regulatory Support: We provide continuous support throughout your product’s lifecycle, including interactions with regulatory authorities, license renewals, and compliance monitoring.
Global Regulatory Expertise: With extensive knowledge of regulations in various countries, we expertly manage submissions to national authorities and registries, helping you mitigate risks and avoid delays.
Tailored Regulatory Consulting: Our services are customized to meet your specific project needs, offering advisory support, documentation management, and regulatory agency communication.
Why Choose Weltrix for Regulatory Affairs
Skilled professionals dedicated to understanding and overcoming regulatory challenges. Comprehensive and transparent regulatory guidance to keep your project on track. Strong partnerships with regulatory authorities and ethics committees. Commitment to quality and timely delivery throughout your regulatory journey.
Let Weltrix be your trusted partner in regulatory affairs, providing the expertise and strategic support you need to achieve successful clinical trial management and product approvals. Contact us today to discuss your regulatory needs and how we can facilitate your path to market.
Clinical Programming
Site selection, patient recruitment, investigator oversight.
Regulatory Affairs
Submission planning, with ICH-GCP, DCGI, and FDA norms.
Biostatistics
Includes EDC systems, analysis, reporting, and clinical study documentation.