Consulting and services for regulatory approval, clinical trials and quality systems in pharma and medical technology
Camara and Partners
Nyon (Switzerland) · Cape Town (South Africa)New on Amplifa
About Camara and Partners
Camara and Partners is a privately managed consulting company founded in Switzerland in 2010 that supports pharmaceutical and medical technology companies throughout the entire product development process. The services include Regulatory Affairs (consulting, dossier preparation, submissions and authority liaison), the set-up and auditing of quality systems (GMP, GDP, GCP ICH E6 R2/R3, ISO 13485, MDR, ISO 14155) as well as locally active Clinical CRO services in Switzerland from study design to clinical study design. Further focal points are medical-scientific consulting, clinical studies in veterinary medicine, import and logistics of investigational medicinal products, and company-specific training, for example on Computerized Systems in Clinical Trials (SwAPP-certified). Since 2025, the subsidiary Camara and Partners South Africa has offered study, regulatory and QMS services including SAHPRA submissions. The expert team has experience from industry, start-ups, hospitals and universities.
- Site
- Nyon
- Processes
- Regulatory Affairs (consulting, dossiers, submissions), Quality Systems – Set up & Audits (GMP, GDP, GCP ICH E6 R2/R3, ISO 13485, MDR, ISO 14155), Clinical CRO Services – study setup & management (Switzerland, South Africa), Medical & Scientific Consulting, Veterinary drug development, clinical trials, agency submissions, Regulatory submissions to SAHPRA (South Africa), Company Training & Coaching (Computerized Systems in Clinical Trials, GAMP 5, Data Integrity), Regulatory Affairs
- Materials
- Regulatory Affairs, Quality Systems (GMP, GDP, GCP, ISO 13485, MDR), Clinical CRO Services, Veterinary Medicine, Services South Africa, Training & Coaching
- Founded
- 2010
- Industries
- Pharma, Medical Technology, Veterinary Medicine
- 01
Regulatory strategy and consulting
- 02
Dossier preparation and submissions
- 03
Quality system set-up and auditing
- 04
Study setup and clinical trial management
- 05
Medical and scientific support
- 06
Import, logistics and training
Services and Areas of Expertise
Regulatory Affairs
Strategic consulting and operational support for approvals and authority interactions.
Quality Systems (GMP, GDP, GCP, ISO 13485, MDR)
Set-up, maintenance and audits of quality systems for pharmaceuticals and medical devices.
Clinical CRO Services
Local clinical trial services in Switzerland from protocol to study report.
Veterinary Medicine
Development and clinical studies for veterinary medicinal products, among others in Switzerland, France and South Africa.
Services South Africa
Study setup, SAHPRA submissions, QMS set-up and company incorporation in South Africa.
Training & Coaching
Company-specific training, e.g. Computerized Systems in Clinical Trials, SwAPP-certified.
Locations
Nyon
CHHeadquarters / Office
Camara and Partners South Africa
ZASubsidiary for clinical trials, regulatory and QMS in South Africa
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Regulatory Affairs (consulting, dossiers, submissions)Engineering | – | – | – | – | – |
| Quality Systems – Set up & Audits (GMP, GDP, GCP ICH E6 R2/R3, ISO 13485, MDR, ISO 14155)Testing | – | – | – | – | – |
| Clinical CRO Services – study setup & management (Switzerland, South Africa)Engineering | – | – | – | – | – |
| Medical & Scientific ConsultingEngineering | – | – | – | – | – |
| Veterinary drug development, clinical trials, agency submissionsEngineering | – | – | – | – | – |
| Regulatory submissions to SAHPRA (South Africa)Engineering | – | – | – | – | – |
| Company Training & Coaching (Computerized Systems in Clinical Trials, GAMP 5, Data Integrity)Engineering | – | – | – | – | – |
Additional services
Reference customers
History
- 2010
Foundation of Camara and Partners as a privately managed company with a focus on Regulatory Affairs and medical expertise.
- 2014
Establishment of a locally active Swiss Clinical Research Organisation; clinical trial services and Quality Systems as a Service.
- 2018
Introduction of clinical trial services in veterinary medicine.
- 2025
Foundation of Camara and Partners South Africa.