Malaysia is regarded as an advanced market for Pharmaceuticals in South-East Asia. With plans to enhance the healthcare system in progress, good demand is projected for pharmaceuticals in Malaysia. The National Pharmaceutical Regulatory Agency (NPRA) is responsible for regulating distribution and marketing of medicinal products in Malaysia. Right from being updated with recent QUEST 3+ submissions to obtaining necessary certifications for active ingredients used in drug formulation, manufacturers may face unexpected procedural challenges.
Keeping abreast with the latest regulations, Freyr offers authoritative Regulatory intelligence apart from catering needed Regulatory assistance as per the regulations i.e, handling QUEST 3+ for all Regulatory submissions for successful compliance. Freyr extends Regulatory support for query response in pre- and post-registration period for the product to be registered.
- Regulatory consultation during the development of the medicinal products like designing of specifications, establishing limits for genotoxic and elemental impurities, and review of protocols/reports for process validation, stability, exhibit batches and analytical method validation
- Regulatory submission road map for medicinal product registration in Malaysia
- Handling QUEST 3+ for all kind of Regulatory submissions to NPRA
- Pre-submission administrative activities, pre-submission interaction with health authority (HA)
- Evaluation of the product source data from R&D and manufacturing site (executed data)
- Compilation and submission of the dossiers to HA in ACTD/eCTD format
- Regulatory consultation during the development of the medicinal products
- Product Registration Holder (PHR) services for both corporate or legal entity in Malaysia
- Post-approval changes submission assisting with strategy and compilation of variation packages
- Change control evaluation and compliance activities
- HA query response support on pre- and post-registration for medicinal products
- HA mandates on drug substance part submission, 1 year prior to the expiry of product registration