Regulatory Services
Labgistics provides end-to-end regulatory affairs services which allow our clients to register their medical devices and drugs in different countries.
Our Services
Regulatory Intelligence
With access to comprehensive regulatory database, we keep abreast of any developments in global regulatory requirements, interpret their impact on products, and provide timely updates and insights to help our clients make informed decisions and implement the most effective strategy to address regulatory needs for each product.
Pre-Submission Capabilities
We develop a solid pre-submission strategy with our expert guidance by conducting thorough assessments of regulatory requirements and determine submission routes, offering strategic recommendations to optimize your submission process and enhance the likelihood of regulatory approval.
Consultation with Health Authorities
We facilitate and conduct consultations with regulatory agencies to gather feedback on regulatory readiness prior to submission of registration ensuring alignment with regulatory expectations and fostering a collaborative approach to compliance, expediting product approval and market access.
Product Registrations and Submissions
Streamline regulatory submission process with our specialised comprehensive end to end regulatory services. From pre-market submission to attainment of pre-market approval, we facilitate timely and compliant submission of dossiers and fulfilment of queries from regulatory authorities.
Pharmacovigilance Expertise
Our Pharmacovigilance services include adverse events (AE) reporting to regulatory authorities, literature screening, regulatory surveillance audits and provide support for global pharmacovigilance requirements to improve benefits-risk ratio on marketed medication and ensure patients safety.
Labelling and Packaging Compliance
Our meticulous review and verification services ensure compliance with regulations on relabeling and packaging. We assess product labelling and packaging materials to ensure alignment with regulatory requirements, minimizing the risk of non-compliance and regulatory scrutiny.
Post Approval Services
Our post approval services ensure ongoing compliance and product integrity. We assist with management of post-approval changes, including product design modifications and intended use updates, as well as license renewals and dossier maintenance, to maintain regulatory compliance and support continued market access.
1. Regulatory Intelligence
2. Pre-Submission Capabilities
3. Consultation with Health Authorities
4. Product Registrations and Submissions
5. Pharmacovigilance Expertise
Our Pharmacovigilance services include adverse events (AE) reporting to regulatory authorities, literature screening, regulatory surveillance audits and provide support for global pharmacovigilance requirements to improve benefits-risk ratio on marketed medication and ensure patients safety.
6. Labelling and Packaging Compliance
7. Post Approval Services
Looking for reliable 3PL and 4PL warehousing and distribution services?
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