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We focus on the following areas of the Life Sciences Industry:
Biotherapeutics, also known as Biological Medicines, are pharmaceutical products that are either produced from living organisms or contain components of living organisms.
Biological Medicines include a wide variety of products derived from human, animal, or microorganisms by using biotechnology. Types of Biological Medicines include vaccines, blood, blood components, Biotherapeutics, biosimilar and recombinant proteins.
Biologic products may contain proteins that control the action of other proteins and cellular processes, genes that control the production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system. Biologic drugs are sometimes referred to as biologic response modifiers because they change the manner of operation of natural biologic intracellular and cellular actions.
A reference product is an already-approved biological product, against which a proposed biosimilar product is compared (FDA definition).
A biosimilar is a biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components and that has no clinically meaningful differences in terms of safety, purity, or potency from an existing reference product. (FDA definition).
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as its brand-name version
Complementary medicines originate from the six (6) major disciplines recognised by the South African Health Products Regulatory Authority (SAHPRA) namely Aromatherapy, Ayurveda, Homeopathy, Traditional Chinese Medicine, Unani Tibb and Western Herbal Medicine, as well as combination products containing a combination of more than one of the disciplines and / or a Health Supplement.
A Health Supplement means any substance, extract or mixture of substances, sold in dosage forms and used or purported for use in restoring, correcting or modifying any physical or mental state by complementing health, supplementing the die, or has a nutritional effect.
An Update on The South African Commenplentary Regulatory Environment – 14/11/2020
The overall aim of the AMRH Programme is to support African countries to improve public health by increasing access to good quality, safe and effective medicines through harmonising medicines regulations, and expediting registration of essential medicines.
Cannabinoid Based Medicine (CBM), also known as Medicinal Cannabis, is cannabis prescribed to relieve the symptoms of a medical conditions. There is a clear distinction between medicinal cannabis and recreational cannabis, with recreational cannabis defined as the form of cannabis that people use to get ‘high’.
There are three main forms of cannabis that can be used medicinally:
A number of therapeutic uses of cannabis have been postulated from preclinical investigations with possible clinical indications include spasticity and pain in multiple sclerosis, cancer-associated nausea and vomiting, cancer pain and. However, evidence is limited, may reflect subjective rather than objective outcomes, and is not conclusive.
Even though regulatory and educational frameworks attempt to support the use of, and access to Medicinal Cannabis, there is still a lot of uncertainty in how to produce, supply and administer cannabinoid products.
|Biosimilars & Generic Medicine||Complementary Medicine||(Medicinal Cannabis) Cannabinoid Based Medicine|
|Scientific Research and Development||Bioequivalence study design||Formulation development||Application of Pharmaceutical R&D principles and method to Cannabinoid Based Medicine|
|Regulatory Compliance||Biostudies & Comparative dissolutions||
|Quality Management & Assurance||Audit support||Applicant service Audit support||Applicant service License auditing, GAP, GMP, GLP compliance Audit support|
|Commercial Excellence||Medical Marketing strategy development||Business Plan development and financial modelling||Business Plan development and financial modelling|
|Education and Training||Education to support Market Shaping strategies|
|Health Economics||Development of Cost minimisation valuation models.
Access and reimbursement negotiation support with funders
|Development of Cost benefit valuation models||Development of Cost benefit valuation models.
Product pricing guidance.