Regulatory Services:
Regulatory services are offered for South Africa and most of English speaking countries in Africa.
Provision of consulting services to the pharmaceutical industry for the following are available:
- Regulatory and Ethics Committee submissions for clinical trials with biological agents and small chemical molecules, medical devices and complimentary medicines including but not limited to Phase I, II and III, Proof of concept, First-in-Man, SAD (single ascending dose) and MAD (multiple ascending dose) Phase I studies.
- Guidance on regulatory strategies in particular for Phase I / Early phase trials with respect to clinical trial design especially for early phase research review of protocols and study related documents for studies.
- Compilation / assessment of applications for regulatory approval of clinical trials (all Phases of research)
- Preparation of periodic progress reports for health authorities and ethics committees.
- Regulatory project management to complement in-house regulatory departments in areas such as
- preparation of major submissions
- development, review and/or updating of Standard Operating Procedures (SOPs)
Back-up services provided: DRConsulting will step in and take over regulatory responsibilities for an ongoing project should you need back-up service during a scheduled or unexpected leave of absence of one of your key staff members.
As an independent consultant/contractor and depending on size and scope of your project, DRConsulting will manage your project either independently or working closely with your regulatory affairs team.
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