The great explorer of the truth, the master-builder of human happiness no one rejects dislikes avoids pleasure itself because it is pleasure but because know who do not those how to pursue pleasures rationally encounter consequences that are extremely painful desires to obtain.
Read MoreRegulatory Affairs Services
TOXVIN Solutions offers comprehensive regulatory affairs services to guide pharmaceutical companies through the complex regulatory landscape and facilitate successful product approvals:
Pre-IND Supporting Documents
We provide expert assistance in preparing pre-Investigational New Drug (IND) supporting documents, including pharmacological and toxicological summaries, to support regulatory submissions and facilitate the IND application process.
Nonclinical Part of IND Package (eCTD Module 2.4 and 2.6)
Our team specializes in the preparation and review of the nonclinical portion of the Investigational New Drug (IND) application package, ensuring compliance with regulatory requirements and facilitating the regulatory approval process.
Preparation of Drug Master Files (DMFs)
We offer support in the preparation of Drug Master Files (DMFs) for regulatory submissions, providing comprehensive documentation of the manufacturing, processing, and testing of pharmaceutical products.
Scientific Advice and Regulatory Strategy
TOXVIN Solutions provides strategic guidance and scientific advice to pharmaceutical companies, helping to navigate regulatory requirements and develop effective regulatory strategies to optimize product development and approval processes.
Regulatory Support on Submission Documentation and Query Responses
Our experienced regulatory affairs team offers support in preparing and reviewing submission documentation, as well as responding to regulatory queries, to ensure timely and successful regulatory approvals.