Trinity Pharma began providing Applicant and regulatory consulting services in 2003. In 2007, the service offering was expanded to include market assessment, regulatory affairs and marketing and distribution advice.
Trinity Pharma is uniquely positioned to help our principal clients in the process of identifying and establishing partnerships with (local or international) marketing firms active in the local and regional pharmaceutical market. Depending on our clients' preferences, Trinity Pharma can form part of such an alliance, or remain completely independent and act solely as regulatory advisory institution. By separating the regulatory and the marketing functions, the client retains a flexibility which can represent an important strategic factor.
Trinity Pharma also established Joint Ventures with selected Marketing partners, ensuring a more cost effective, but highly aligned partnership for principals, in those cases where the Joint Venture represents the ideal vehicle on a product specific basis.
Through its a strategic alliance with a Black Economic Empowered company, Trinity Pharma is active in supplying products to the South African public sector, both through tenders and buy outs.
Trinity Pharma, through its extensive network and contacts in African countries, south of the equator, sources products internationally and supplies directly to these countries. As these markets are far less regulated, Trinity Pharma is able to start selling their customer’s/supplier’s products into these territories before their products are registered in South Africa.
We are deeply committed to satisfactorily meeting and exceeding our clients’ sales ambitions and their need for reliable service by providing high quality and commercially minded advice and responding quickly to clients’ concerns.
Trinity Pharma's areas of expertise
Complementaries (including Homoeopathic and Herbal medicines, Foodstuffs and Cosmetics.)
We rely on our insights in the local market, longstanding relationships with key industry and government stakeholders, and marketing and sales expertise to ensure your success in Southern Africa.
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- Regulatory market orientation
- Cost estimate for registration process
- Estimating market potential
Trinity Pharma fulfills all regulatory requirements and is able to act as the local applicant for its client's products.
- Fully licensed pharmaceutical company
- Responsible pharmacist
- Team of experienced consultants to supervise & manage registration process
- Trinity Pharma acts as the Holder of Certificate of Registration (HCR) and accompanies the commercialization process of the product:
– Pharma-covigilance processes
– Obtain approval for packaging design
& package inserts
– Obtain approval for marketing
– Adherence to SA Marketing Code
– Product/batch release upon
- Advise on the optimal marketing & distribution approach and act as
intermediary where required
Business Development - Market Orientation
Trinity Pharma strives to make its client's case to enter the African market as sound as possible.
Trinity Pharma currently offers the following services:
- Regulatory Market Orientation Report – Provision of the necessary information with regards to processes and procedures that need to be considered and which requirements to fulfill in order to commercialize products in South Africa.
- Cost Estimates – Costs drivers that need to be considered during and after registration for all matters related to pharma-covigilance.
- Market Potential Assessment – Sizing of the market opportunity
Pre-Marketing Authorization Process - Product Registration
The process of registering a product for sale in South Africa can be time consuming as well as expensive if no local partner or subsidiary is available.
- Trinity Pharma is registered as a fully licensed pharmaceutical company and is in a position to act as the Applicant and, post-registration, as the "Holder of the Certificate of Registration" (HCR) on behalf of its clients.
- As the Applicant/HCR for a product Trinity Pharma will continuously monitor and advance the registration process and maintain the dossier for the client also after the product is successfully registered.
- Trinity Pharma consults its clients at every stage to ensure a smooth and trouble free registration process.
Trinity Pharma's consultants are highly experienced in the entire registration process and we thus ensure the highest quality regulatory support.
- Trinity Pharma's Responsible Pharmacist takes ownership of our clients' regulatory needs.
Services: Product Registration
Following registration of the product, Trinity Pharma continues its oversight of regulatory requirements and ensures that the clients' products are and remain in compliance with South African legislation and policies.
Some of the activities that Trinity Pharma performs in this regard are:
- Post-registration amendments and dossier maintenance
- Pharma-covigilance e.g.
- Reporting of adverse events
- Product withdrawal or recall
- Marketing and advertising material review and approvals
- Training of sales representatives
- Final product release following importation or manufacture
- GMP compliance
- Auditing in terms of the GMP requirements for applicants
- Vendor inspections and approvals
Services: Marketing and Distribution
Trinity Pharma has been highly successful in acting as intermediary between Principal and Marketing partner.
Due to our broad and deep networks, and our reputation in the industry, we are able to identify the optimal Marketing partner per product, according to the clients' needs and wishes.
Furthermore Trinity Pharma can also participate in tenders on the clients' behalf where products qualify for this.
In 2009, Trinity Pharma started to in-license certain products, and has launched them in South Africa under its own umbrella brand. We are actively looking for additional, similar opportunities.
In such a scenario Trinity Pharma will acquire the license to market and distribute a product. Trinity Pharma can also take on the responsibility to register the product with the relevant regulatory authorities.