Trusted Partner for Regulatory Lifecycle Management
Regulatory Lifecycle Management (RLM) services for pharmaceutical and medical device companies involve the management of regulatory submissions and approvals throughout the product lifecycle. The goal of RLM is to ensure that a product remains compliant with regulatory requirements and that necessary approvals are obtained for new uses, changes, or updates to the product.
At Techsol, our expert team of Quality & Regulatory professionals have extensive scientific knowledge, and regulatory experience in contributing to clinical development programs for global pharma companies. We provide our expertise on regulatory compliance requirements, including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP). Additionally, clients leverage our advisory capabilities to prepare for as regulatory audits and inspections.
How We Can Help
Following are the key focus areas where our team has the expertise to deliver high-quality regulatory services throughout the drug / device development lifecycle:
Regulatory Strategy Development
Our team can provide expert regulatory guidance to bring a product to market and ensuring compliance with relevant gloabl and regional regulations.
Clinical Development Support
We can be a reliable partner to assist with the planning, conduct, and reporting of clinical trials to ensure that the data generated is acceptable for regulatory submissions.
Leverage our expertise for the preparation and submission of regulatory applications to obtain marketing authorization for a product, including new drug applications (NDAs), biologics license applications (BLAs), and medical device submissions.
Post-marketing Regulatory Support
Our PV & Regulatory team’s expertise can be leveraged for safety monitoring and pharmacovigilance. We offer extended support for completing new market product registrations, obtaining marketing licenses and complying to applicable regulations during the post-marketing phase.
We specialize in monitoring regulatory updates and implementing necessary processes to comply with legal obligations during the entire product lifecycle. This includes completing regulatory gap-analysis, risk management and providing inputs for preparing for audits and inspections.
Regulatory Information Management
To streamline regulatory documentation management, our team can provide practical guidance to setup a RIMS system. We have helped companies to digitalize the end-to-end management of regulatory documents and transition from a manual paper-based disconnected process.