At Asphalion, we specialize in providing comprehensive medical and scientific writing services tailored to meet the unique needs of startups, biotech, and pharma companies. Our experienced team ensures your regulatory documentation is accurate, compliant, and submitted on time, every time.
Key Benefits:
- Expertise in Global Regulatory Requirements: Our team has in-depth knowledge of regulatory requirements across various regions and product types, including small molecules, biologics, and advanced therapy medicinal products (ATMPs).
- Customized Solutions: We provide tailored solutions for every stage of product development, ensuring that your specific needs are met efficiently.
- Time-Efficient and Cost-Effective Processes: We streamline our processes to save you time and money, ensuring your projects stay on schedule and within budget.
We handle both clinical and non-clinical modules with precision, ensuring that every part of your dossier meets the highest standards. Our services include:
- Preparation of Investigator’s Brochure (IB) and IMPD for Clinical Trial Applications in the EU and INDs for the US.
- Preparation of Non-Clinical (M 2.4, 2.6, 4) and Clinical (M 2.5, 2.7, 5) parts of the eCTD dossier for EU and US.
- Non-Clinical and Clinical Reports Updates for lifecycle management.
With over 20 years of experience in medical and scientific writing and more than 800 successfully completed projects, Asphalion is your reliable partner for navigating the complexities of regulatory submissions with confidence. Contact us today to learn more at [email protected].
Building Foundations for Strong Non-Clinical and Clinical Developments
Asphalion’s Medical and Scientific Writing team supports you in building the foundations of robust non-clinical and clinical developments. Our team members possess extensive academic research experience and a broad scientific background, including non-clinical, clinical, and Chemistry, Manufacturing, and Controls (CMC) writing for diverse product types, such as innovative, biological, biotechnological, and advanced therapy medicinal products.
Asphalion’s expertise enables us to offer the best regulatory strategy for each project. We provide support with all types of regulatory-related documentation required during clinical development and registration. Additionally, we offer strategic inputs from the very beginning, including:
- Segmentation/niche indication
- Conditional approval/fast track
- Orphan drug designations
- Preclinical and clinical development plans with minimal time-to-market
Medical and Scientific Writing Solutions
We provide specialized expertise in key areas, ensuring a smooth and efficient path to product approval and commercial success:
- Complete Module Elaboration: Non-Clinical and Clinical sections according to legal basis (Modules 2, 4, and 5).
- Non-Clinical and Clinical Expert Signatures: Certification of dossiers by our expert team.
- ACOs/ANCOs: Assistance with the preparation and submission of these critical components.
- Preparation of RMPs, PSURs, and DSURs: Risk Management Plans, Periodic Safety Update Reports, and Development Safety Update Reports.
- Study Protocol Drafting and Review: Comprehensive support in creating and reviewing study protocols.
- IMPD/IND and Investigators Brochure (IB) Writing: Detailed preparation for clinical trial applications.
- Applications for Line Extensions to New Indications: Expertise in expanding the indications for your products.
- Responses to Agencies and Justification of Questions: Professional handling of regulatory agency queries.
- Bibliographic Searches and Compilations: Thorough literature searches to support dossiers and responses to agencies.
Partner with Asphalion to navigate the complexities of regulatory submissions with confidence. Our comprehensive services and expert team ensure that your medical and scientific writing needs are met with the highest standards of quality and compliance.
Contact us today at [email protected] to learn more about how we can support your regulatory needs.
