Regulatory services
Regulatory approval processes vary across countries and product segments. Africa presents its unique regulatory landscape, necessitating the expertise of an organization that is well-versed in the region’s intricacies and is intimately familiar with its regulatory processes.
Clinique Research’s on-the-ground presence offers a distinct advantage and unparalleled access to navigating the regulatory landscape.
- We facilitate regulatory support for clinical trial approvals, ethics committee clearances, and import/export permits.
- We also provide support for health-care product registration and marketing authorization approvals.
- We are dedicated to ensuring that trials are conducted ethically and under the guidance/regulations/approvals of situated ethics committees and regulatory authorities.
- We facilitate study submissions on behalf of our clients, utilizing a structured approach to collect regulatory documents efficiently.
- We expedite the start-up timeline by providing clear instructions and expectations for completing documents accurately and promptly. This approach aims to ensure timely submissions and faster approvals, ultimately facilitating smoother project initiation.
Regulatory Support We Provide
Advisory & Consultancy Services
Clinique Research provides advisory and consulting services for pharmaceutical and biotech organizations interested in Africa, helping them navigate the system to meet their goals.
Regulatory Applications
A meticulously prepared application is crucial for successful regulatory approval. We ensure detailed submissions that fulfil all the requirements of the regulatory body.
Regulatory Feasibility Assessment
Assessing the feasibility of regulatory requirements can significantly save time and resources in attaining successful regulatory approval. This evaluation determines whether the client’s product may be approved upon submission.
Pharmaceuticals
Pharmaceuticals and biological products such as vaccines and gene therapies are the leading treatment and preventive solutions worldwide. Adhering to regulatory application and approval guidelines is essential to prevent delays and extensions of study timelines.
Nutraceuticals and Supplements
Nutraceuticals, dietary supplements, cosmetics, and other complementary medicines constitute a substantial portion of healthcare products worldwide. The increasing demand for these products has prompted a greater understanding of their regulatory approval processes.
Medical Devices
Physical and supporting devices are among the most widely used medical devices globally, serving diverse purposes. The marketing authorization process varies from country to country.
Clinique Research offers comprehensive support for all the aforementioned products. From advisory and consulting services to regulatory assistance for product registrations and approvals related to clinical trials, we provide tailored support to meet our client’s needs.
Specific information
Before preparing the documents for your application, it may be necessary to clarify specific information or address important questions. We are readily available to facilitate meetings between our clients and regulatory bodies applicable to the country where your product submission will be conducted.
Pharmaceuticals
Pharmaceuticals and biological products such as vaccines and gene therapies are the leading treatment and preventive solutions worldwide. Adhering to regulatory application and approval guidelines is essential to prevent delays and extensions of study timelines.
Nutraceuticals and Supplements
Nutraceuticals, dietary supplements, cosmetics, and other complementary medicines constitute a substantial portion of healthcare products worldwide. The increasing demand for these products has prompted a greater understanding of their regulatory approval processes.
Medical Devices
Physical and supporting devices are among the most widely used medical devices globally, serving diverse purposes. The marketing authorization process varies from country to country.
Clinique Research offers comprehensive support for all the aforementioned products. From advisory and consulting services to regulatory assistance for product registrations and approvals related to clinical trials, we provide tailored support to meet our client’s needs.
Specific information
Before preparing the documents for your application, it may be necessary to clarify specific information or address important questions. We are readily available to facilitate meetings between our clients and regulatory bodies applicable to the country where your product submission will be conducted.