Our Services
We understand the specialised skills required for regulatory affairs, to navigate the complex African landscape, and balance commercial priorities. We have tailored our services to suit various pharmaceutical products, for local and multi-national companies, across a spectrum of compliance activities. If you require a service we have not listed here, please contact us, to assess your needs and revert with a solution.
We help enhance compliance practices to optimise efficiencies cross-functionally, and enable faster access to much needed medicines.
Licencing of Premises: We offer specialised and rigorous licensing of premises under the guidance of the SAPC, DoH and SAHPRA. Our team ensures that your premises meet all required regulatory standards, so you can operate with confidence.
Quality Services: We help you prepare for audits and inspections, by reviewing your entire quality system, and providing tailored guidance and hands on support to ensure compliance in all areas - premises, people, processes, procedures, products and more!
ISO 13485 Compliance: We offer support for ISO 13485 compliance, ensuring that your organization meets international quality standards for medical devices.
Pharmacovigilance: Our comprehensive pharmacovigilance support covers monitoring, assessing and preventing adverse effects of pharmaceutical products, in line with strict regulatory requirements.
With our key offering of expert regulatory services, and our expanded compliance services, we aim to continue providing our clients with top-tier solutions to their needs, delivering the utmost level of professionalism. Trust us to take your business to the next level.
Regulatory Strategy & Submissions
A clear strategy is key to ensure shortest registration timelines. Our team will work with you to set the strategy and compile submissions for:
- New product registrations
- Variations (CMC & Labelling)
- Renewals
- Miscellaneous regulatory correspondence.
Lifecycle Management
We understand the importance of maintaining licences proactively, to ensure compliance of dossiers and mitigate supply risks, and offer the following services:
- Supply Risk assessment and Mitigation plans
- Tracking and co-ordinating past, current, future activites.
- Dossier Due Diligence
- Dossier base-lining
- Consolidating activities for artwork development.
Systems & Process Optimisation
While technology advances, it is imperative to keep pace with global developments and align with health authority systems. We work with you to assess and maintain current systems and processes, to optimise efficiencies.
- Document & Data Management
- Regulatory Information Management Systems, Tracking Tools, Digital platforms.
- Standard Operating Procedures (SOP's) & Guidance Documents
- Training Systems / portals
- Health authority portals
GxP & ISO 13485 Compliance
Audits and inspections are critical activites in ensuring compliance and patient focus in all functions, We review current regulatory practices and aid in audit and inspection preparations for perpetual readiness, to help avoid unwelcome surprises.
- Quality Management System
- SOP review and update
- Risk Management
- Change Control
- Deviations
- Root Cause Analysis
- Corrective & Preventive Actions
- Self-Inspections
Promotional Reviews
We are equipped to balance compliance and commercial requirements to ensure sound scientific and marketing messages in promotional material. We review elements and aid in launch preparations for various product classifications:
- Cosmetics
- Consumer products (S0 and general sale)
- OTC (Over the counter) medicines (S1, S2 and Pharmacy only).
- Prescription Medicines
- Complementary Medicines
- Medical Devices
Labelling & Artwork
We understand the risks to patients, with inaccurate labelling and artwork for printed packaging material.. As a separate workstream within lifecycle management, we create and update text for:
- New registration applications
- New indications and safety updates.
- Artwork updates for new and existing licences (consolidating CMC & Labelling changes).
- Shared packs involving multiple languages.
Regulatory Intelligence
The first step to compliance is awareness and understanding of legislative requirements. Our team monitors the African regulatory landscape to help plan for future compliance requirements and mitigate risks:
- Track and Identify changes / updates
- Assess risks to all stakeholders
- Change Control
- Implementation
- Ongoing Evaluation
Talent Development
We understand the importance of developing people in the highly specialised regulatory field, With our global exposure, extensive experience and active industry engagment, we are equipped to support people through:
- Training
- Coaching
- Mentoring