Regulatory
Asterisk is committed to upholding the regulatory compliance and code standards applicable for its manufacturing, R&D, and development facilities. Our regulatory protocol includes all services from primary assessment, evaluation, and scrutiny over product lifecycle, to dossier development, submission, and approval acquisition.
Our strong dedicated team of 20 pharma regulatory personnel mitigate product registration risks & delays, thereby proactively ensuring the timely registration of products in target markets. This consistent speed and accuracy of our regulatory team ensure the timely launch of products & help meet revenue targets.
We ensure the timely execution of plant audit processes and stay accountable to the directives from global regulatory bodies. Our Regulatory Affairs department, continually develops and executes regulation-based responsive strategy that ensures the collective efforts of the Drug Development team result in products that meet the requirements of global regulators but are also differentiated from our competition.
In all our undertakings, we make sure that all activities, right from primary, non-clinical research to advertising and promotion, are conducted in accordance with the regulations, guidelines, and requirements established by global regulatory authorities, ensuring that the teams work within a regulatory-centric paradigm within the Asterisk ecosystem.
Our compliance and regulatory professionals, stationed across the globe, closely monitor the product dossier data generation from manufacturing units, with periodical and random quality checks through the year.
Pre-registration
- Consultation to provide insight into markets
- Regulation assessment to design effective strategy
- Watch on constantly changing industry registration and FDA/ MOH requirements
- Feasibility assessment
- Labelling requirement assessment
- Product classification assessment
Registration
- Product registration from start to finish
- Product dossier review to establish effective approach
- Gap analysis
- Prepare document requirement for submission to regulatory agency
- Respond to queries from regulatory agency
- Provide the final registration certificate
Post-marketing Obligations
- Advertising compliance checks
- Pharmacovigilance
- Product license renewal
- Post market surveillance
- Safety reporting and submission of period reports
