PrimeReg Consulting
We are specialist regulatory consultants with in-depth knowledge and experience in the regulatory landscape which is increasingly essential in advancing health products and other technical innovations.
Our strength lies in our passion for healthcare by offering best-in-class expertise in the health and medical fields. We also offer specialist marketing and formulation development.
Attention to detail and superior service characterize our consulting group. From initial client contact to completion of work, we are committed to delivering quality projects while maintaining confidentiality in the interest of our multinational clients.
Reduce the administrative burden of compliance. A proven and effective regulatory strategy that provides oversight and reduces the time, cost, and risk associated with managing your own compliance program. Our Regulatory services are delivered on a flexible basis, which means we can adapt our services as an ever-changing regulatory environment evolves.
We provide a complete and total range of regulatory services. In order to minimize any delays due to regulatory non-compliance, we have distinguished experts in industry-leading roles. We offer comprehensive knowledge of the regulatory frameworks that apply to our clients, and the industry, the ability to evaluate new regulations, and provide methods of continuous compliance with the latest developments.
Ensure compliance and stay ahead of the competition.
Our Best-In-Class Services
At PrimeReg Consulting, we offer a comprehensive suite of services tailored to your regulatory and business needs:
01
Compilation of Regulatory Documentation
- MF, QMS, SOPs, MSDS, Dossiers: We ensure your documentation is meticulous and compliant.
- AnnexureB Applications: Seamlessly prepare and submit AnnexureB
applications. - License Submissions (Online Portal): Simplify the process with our expertise.
- SAPC License Submissions: Trust us to handle your license submissions with precision.
- Product Formulations: We scrutinize and optimize your product formulations.
- Label Conformance: Ensure your labels meet all regulatory standards.
02
Due Dillegence
03
Formulation
- Complementary and Personal Care Products: Let us formulate products that stand out.
- Contract Manufacturer Liaison: We negotiate for the best prices and formulations on your behalf.
- Route to Market: We strategize the most efficient routes to market.
- Pharmaceutical Retailers, Wholesalers, and Agents: Our team liaises with them on your behalf.
- Substantiating Regulatory Requirements: We ensure compliance at every step.
- Product Listings: Navigate the channels smoothly with our expertise.
04
Project Management
05
Digital Marketing
In collaboration with Outspire’s marketing services, Outspire encompasses a wide range of solutions, including market research, competitive analysis, brand development, digital marketing strategies, social media management, content creation, and public relations support. By implementing these services, Outspire ensures that PrimeReg empowers clients to navigate the complex regulatory environment with agility while effectively promoting their products or services to their desired target market.
Proud Member of the Health Products Associations of South Africa
Get in touch with Us!
Let Us Know How We Can Help You!