Pharmaceutical Formulation - Tenax Enterprises

Formulation & Product Development

Tenax Enterprises offers end-to-end formulation and product development services, taking products from initial concept through to compliant, market-ready dosage forms.

Industry-Leading Product Formulation Capabilities

Our capabilities in this area are unmatched in the region: to date, we have successfully formulated twelve products across multiple categories for clients spanning the pharmaceutical, cannabis, complementary medicines, nutraceutical, cosmetic, and food and beverage sectors.

We pair deep formulation science with regulatory and quality insight from the outset, so that every product is engineered to satisfy SAHPRA, BOMRA, other African regulatory authorities, EMA, and FDA requirements before it ever reaches a dossier.

Formulation & Development Support

Whether you are developing a generic, a complementary medicine, a cannabinoid product, or a cosmetic line, our formulation services are tailored to your product, your target markets, and your route to registration. Our services include:

1. Concept, Feasibility & Pre-Formulation

Translate product ideas into technically and commercially viable formulation concepts, with an early read on the applicable regulatory pathway and product classification.
Conduct pre-formulation studies, including active ingredient characterisation, excipient compatibility screening, and solubility and stability profiling.
Advise on dosage form selection (oral solids, liquids, semi-solids, topicals, oils, and others) to balance efficacy, manufacturability, and compliance.

2. Formulation Development & Optimisation

Develop robust, reproducible formulations using a quality-by-design (QbD) approach aligned with ICH Q8 principles.
Optimise formulations for stability, bioavailability, palatability, and cost-efficiency without compromising regulatory acceptability.
Define critical quality attributes (CQAs) and critical process parameters (CPPs) to support consistent, scalable manufacture.

3. Cannabis & Cannabinoid Formulation

Formulate cannabis and cannabinoid products — including oils, oral preparations, and topicals — in line with SAHPRA’s requirements and the relevant scheduling of cannabis and CBD under the Medicines and Related Substances Act, 1965.
Navigate the Schedule 4 CBD exemption framework and supporting compliance positioning for finished products.
Support standardisation of cannabinoid content and develop formulations suited to GACP- and GMP-aligned supply chains.

4. Complementary Medicines & Nutraceutical Formulation

Develop complementary and alternative medicines (CAMs), health supplements, and nutraceuticals compliant with SAHPRA’s complementary medicines framework and applicable category and discipline call-up requirements.
Formulate herbal, homeopathic, and nutritional products with consistency and efficacy as design priorities
Align label claims and product compositions with the supporting evidence and regulatory expectations from the development stage.

5. Cosmetic & Personal Care Formulation

Develop cosmetic and personal care formulations that meet South African requirements and align with EU and FDA cosmetic standards for export markets.
Ensure ingredient compliance, preservative efficacy, and appropriate safety substantiation.
Support claim substantiation and the technical content required for product information files.

6. Stability Studies & Analytical Support

Design and oversee stability programmes in accordance with ICH Q1A(R2) and SAHPRA stability guidelines to establish shelf life and storage conditions.
Coordinate analytical method development and validation in support of release and stability testing.
Interpret stability and analytical data to refine formulations and substantiate registration claims.

7. Scale-Up, Technology Transfer & Manufacturing Support

Scale formulations from bench to pilot to commercial batch while preserving product quality and regulatory consistency.
Manage technology transfer to contract manufacturers, including process documentation, batch records, and in-process controls.
Provide formulation and quality oversight throughout outsourced and contract manufacturing engagements.

8. Regulatory-Aligned Documentation

Compile formulation development reports, pharmaceutical development sections, and supporting Module 3 / quality documentation for SAHPRA, BOMRA, EMA, and FDA submissions.
Ensure formulation data integrates seamlessly into the registration dossier and withstands regulatory and inspection scrutiny.
Build an audit-defensible development record from the first batch, so that nothing has to be reconstructed at submission stage.

A proven track record.

Twelve products formulated. Multiple categories. One standard of excellence. Guided by our mantra, “The Audacity to Try”, we partner with innovators to turn formulation ambition into compliant, commercial reality

Formulation & Product Development

Tenax Enterprises offers end-to-end formulation and product development services, taking products from initial concept through to compliant, market-ready dosage forms.

Industry-Leading Product Formulation Capabilities

Formulation & Development Support

Whether you are developing a generic, a complementary medicine, a cannabinoid product, or a cosmetic line, our formulation services are tailored to your product, your target markets, and your route to registration. Our services include:

A proven track record.

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