Regulatory and Compliance
Our regulatory and compliance consulting services help pharmaceutical companies navigate complex regulatory requirements, ensuring products meet global standards while minimizing time-to-market.
SAHPRA LICENSING SUPPORT
Build your business on a
strong regulatory foundation.
You have a business to build, products to bring to market and people counting on you. Your regulatory pathway needs to be clear from the start.
PharmAlign Solutions provides end-to-end SAHPRA establishment licensing support for medicines and medical-device businesses across manufacturing, import, export, wholesale and distribution, under the applicable pathway. We connect licence applications, quality systems, site readiness and query responses, alongside support for product registration dossiers and device technical documentation where applicable.
✓ Clear regulatory pathway ✓ Application support ✓ Operational readiness
See our licensing approach · 40 seconds
Our Approach
Our regulatory and compliance consulting services help pharmaceutical companies navigate complex regulatory requirements, ensuring products meet global standards while minimizing time-to-market.
Strategic Planning
Developing regulatory roadmaps tailored to your specific products and target markets
Representation
Acting as your regulatory representative with health authorities
Documentation
Preparing and reviewing regulatory submissions to ensure compliance and approval
Compliance
Ensuring ongoing adherence to changing regulatory requirements
Regulatory Compliance Services
GMP Compliance
Comprehensive GMP and regulatory consulting services to ensure your operations meet global standards including:
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PIC/S GMP compliance assessments
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WHO and SAHPRA regulatory requirements
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Gap analysis and remediation planning
Licensing & Submissions
Expert assistance with regulatory documentation and submissions:
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Import license applications (CAT A, B, C, and D)
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Dossier preparation and submission
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Regulatory correspondence management
Audit Services
Comprehensive audit preparation and execution:
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Supplier qualification audits
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Mock regulatory inspections
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Internal compliance audits
