Your Trusted Partner in Regulatory Affairs
GH Strategies delivers specialised regulatory affairs expertise to ensure accurate classification, compliant dossier development, and timely market authorisation.
What We Offer
SAHPRA Establishment Licensing
Comprehensive support for securing pharmaceutical and medical device establishment licences, ensuring alignment with regulatory and operational criteria.
New Product Registration and Dossier Compilation
Strategic preparation, compilation, and lifecycle management of dossiers to facilitate efficient and compliant product registration.
Clinical Trial Applications and Amendments
Expert development and submission of clinical trial applications and protocol amendments consistent with SAHPRA and international research standards.
Section 21 Applications
Efficient processing of Section 21 submissions for unregistered medicines, enabling compliant and controlled patient access.
Regulatory Due Diligence and Compliance Audits
Detailed assessments to identify gaps, reduce risk, and maintain regulatory integrity for audits and inspections.
Promotional Material and Labeling Compliance
Technical review and approval of labels, packaging, and promotional content in accordance with SAHPRA and global regulatory requirements.
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Benefits of Choosing GH Strategies
Global Standards, Local Expertise
End-to-End Partnership
Strategic Growth Enablement
Regulatory Strategy Engineered for Performance
Strategic regulatory methods that enhance submission quality, reduce review cycles, and align documentation with SAHPRA and global standards.
Frequently Asked Questions (FAQs)
Regulatory affairs consulting ensures that pharmaceutical, medical device, and IVD companies meet the legal, technical, and quality requirements necessary for market approval. GH Strategies supports clients by interpreting regulatory expectations, preparing compliant documentation, designing robust submission strategies, and reducing approval risks across the product lifecycle.
Registration requires a complete CTD (for medicines) or a technical file (for medical devices and IVDs), correct product classification, supportive clinical or performance data, and compliance with SAHPRA guidelines. GH Strategies oversees the entire process, from classification and dossier development to submission and lifecycle management.
Timelines depend on the product category, submission type, and the completeness of documentation. Applications that are inconsistently prepared often experience significant delays. GH Strategies ensures dossiers are complete, structured, and ready for efficient screening and evaluation.
Requirements typically include CTD Modules 1–5, product labelling, stability data, manufacturing information, risk assessments, performance or clinical evidence, quality reports, and proof of Good Manufacturing Practice (GMP). For devices and IVDs, a full technical file aligned with the risk class is required. GH Strategies compiles and reviews all documentation to ensure compliance.
Yes. Medical devices and IVDs must be correctly classified and registered with SAHPRA before being marketed or distributed. GH Strategies assists with classification, dossier preparation, and technical documentation aligned with the product’s risk class and local regulatory requirements.
SAHPRA applications are often delayed or rejected due to incomplete documentation, incorrect product classification, inconsistent manufacturing information, missing stability or clinical data, and dossiers that do not follow the required structure. GH Strategies reduces these risks by ensuring that applications are complete, technically sound, and aligned with current regulatory expectations before submission.
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