Overview
Navigating the complex Regulatory landscape of the life sciences industry requires industry insights coupled with unparalleled expertise. We at Freyr provide comprehensive Regulatory services globally, ensuring that your medicinal drug products (pharmaceutical (Rx/OTC), biologicals) comply with stringent Regulatory requirements, and current recommendations and achieve successful approvals and market entry.
We specialize in providing Regulatory expertise for the US FDA, EU, and Health Canada, our team offers end-to-end support to streamline your product's journey from development to market entry and beyond.
Our services encompass technical review, finalization, and submission of complete Regulatory packages, ensuring compliance with global standards and specific HA requirements. Our pre-submission support includes Regulatory strategic submission plans, Regulatory roadmap, and comprehensive reviews to ensure all Regulatory requirements are met. Freyr extends support with regard to clinical, non-clinical, Labeling, Artwork, Pharmacovigilance, and electronic Publishing and Submission domains to provide end-to-end registration support.
Global Health Authorities-Specific Services
- Providing strategic Regulatory consultation
- Drawing Regulatory roadmaps/ pathways
- Strategic guidance during the development stage of the medicinal products
- Preparing and submitting pre-submission meeting packages
- Leading and participating in health authority interactions
- Gap analysis of source documents and providing mitigation guidance for identified gaps
- Authoring of CTD/non-CTD dossiers in line with country-specific requirements
- Providing strategy and preparation of response package to HA deficiencies
- Control assessment and global post-approval submission strategy
- Review and preparation of post-approval variation packages
- Preparation and submission of life cycle management submissions like annual reports and renewals
- Authoring of administrative submissions
- Expert registration support for all types of medicinal products, including biologicals, prescription and OTC pharmaceuticals, innovator and generic drugs, combination products, APIs, excipients, and package materials across all therapeutic categories
- Expert registration support for all dosage forms, such as orals, injectables, ophthalmics, otics, topicals, transdermal patches, inhalers, aerosols, and drugs in all therapeutic categories
- Utilization of in-house developed automation tools to enhance submission accuracy and efficiency
- Proficient in handling end-to-end Regulatory registration activities
- Complete ownership by Freyr for successful registration and approval
- One-stop solution for all Regulatory registration activities
- Extensive support for expedited review programs and special Regulatory designations
