Tailored Solutions
for your business.
Our Services
Holistic Services
We offer a wide range of services, including gap analysis, dossier coordination, product registration, post market support, guidance and insights, quality management and sourcing.
MALAYSIA AND SINGAPORE
Holistic Services
We handle product registration for new drugs, biologics/biosimilars, vaccines, generics, OTC products, health supplements, cosmetics, medical devices (general and IVDs), and combination products (drug-device/ device-drug).
Full handling
Start of dossier receipt to the end of the registration submission application process.
Pre-Submission Gap Analysis
Identify dossier gaps and minimize withdrawal risks and costs.
Post-registration support
Handle the product lifecycle, including:
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Variations, new/additional indications, line extensions, change notifications.
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Licences and Special permits
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Registration renewals
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Re-registration
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Advertisement and promotional materials reviews.
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Licences transfer
Liaison
Liaison and facilitate communication with health authorities and manufacturers.
Guidance and Insights
Providing guidance to individuals or groups with valuable insights into the pharmaceutical, medical device (both general and IVDs), and combination product registration processes. SKRA's tailored services encompass guidance and product registration walkthroughs. This practical advice not only streamlines the registration plan but also enables well-informed business decisions, giving business owners the strategic edge they need to expand and achieve their goals.
Quality Management
Services include GDPMD/Establishment License setup and GMP assistance on case to case basis.
Situational Management
We offer other regulatory services, such as product recalls, pharmacovigilance, transfer of product registration holder, and post-market surveillance audits. Our team steps in to address any human resource gaps in matters related to regulatory compliance.
Sourcing
Assisting in sourcing laboratories, clinical research centers, and distributors related to regulatory projects on case to case basis.
OTHER ASEAN COUNTRIES
We serve as Regulatory Affairs project managers, coordinators, and single points of contact for dossiers, resolving the product registration deficiencies. This role reduces redundancy, enhances process effectiveness, and includes:
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Dossier conversion to ACTD and CTD formats
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Handling ad hoc regulatory projects to streamline the process.
