Cara Humphrey

Senior independent consultant with more than 20 years' experience in formulation and product development, and 12 years' experience in regulatory affairs across health supplements, nutraceuticals, specialised nutritional products and FSMPs. Provides remote, project-based consulting to regulatory affairs teams, manufacturers and product-development teams across South Africa, the UK, Australia and Canada. Expertise includes formulation and product regulatory strategy; formulation and claims remediation before and after submission; product classification; ingredient and dose review; safety and efficacy evidence assessment; clinical literature reviews; claims substantiation; label-support content; warnings; and consumer-information review.

Prepares and reviews clinical evidence summaries, Clinical Overviews, Clinical Summaries and scientific content for local regulatory submission packages, including CTD/eCTD-ready documentation.

Regulatory Affairs & Product Development Consultant - Self-employed - Remote, South Africa | UK, EU, Canada, Australia, Middle East

(2014-01)

I provide regulatory affairs, clinical evidence, and product-development support to health-supplement, nutraceutical, FSMP and specialised-nutrition product teams.

• Develop formulation and product regulatory strategies.
• Review and support formulation remediation before and after submission.
• Assess safety and efficacy evidence.
• Conduct product classification, ingredient and dose reviews.
• Review claims and prepare claims-wording rationale.
• Conduct clinical literature reviews and prepare evidence summaries.
• Review label-support content, warnings and consumer information.
• Prepare clinical and scientific content for country-specific regulatory packages.
• Prepare and review Clinical Overviews and Clinical Summaries, including eCTD Modules 2.4, 2.5, 2.6 and 2.7.

Product Development Consultant - Self-employed - South Africa | International

(2001-01 - 2024-12)

Over more than 20 years, supported health and wellness brands to convert market opportunities into commercially viable health supplements, nutraceuticals, FSMPs and specialised nutritional products.

• Led product research, formulation and development work.
• Developed products containing vitamins and minerals, amino acids, peptides and proteins, speciality nutrients, herbal and botanical extracts, and multi-nutrient blends.
• Prepared clinical evidence reviews and technical documentation to support product submissions and commercial launches.
• Conducted active-ingredient, nutrient-interaction and formulation assessments.
• Contributed as nutritional consultant to the Regulatory Advisory Group project supporting the development of SAHPRA Category D regulations for health supplements and complementary medicines.
• Provided support for products intended for South Africa, the UK, EU, Canada, Australia and the Middle East.

Supplement Platform Consultant - Self-employed - South Africa | Middle East

(2021-03 - 2023-01)

• Designed a supplement-recommendation framework and digital health questionnaire.
• Developed safe, tailored recommendation criteria and selection rules.
• Defined product-selection criteria based on safety, quality and suitability.

Clinical Nutrition Practice - Self-employed - South Africa | International

(2001-01)

Established and managed an HPCSA-registered nutrition practice. Consults part-time with patients and to chronic-condition programmes.

Applied Functional Medicine in Clinical Practice - Institute for Functional Medicine (2012-01 - 2012-12)

Postgraduate Diploma in Sports Nutrition - Sports Nutrition - International Olympic Committee (2006-01 - 2007-12)

Postgraduate Diploma in Business Management - Business Management - Wits Business School (2000-01 - 2002-12)

Postgraduate Diploma in Dietetics, Clinical Nutrition - Dietetics, Clinical Nutrition - University of Natal (1996-01 - 1997-12)

Bachelor of Science in Dietetics - Dietetics - University of Natal (1991-01 - 1996-12)