Effective Project Managers are essential for managing the study team and meeting project time-lines. Clinique Research Services, Inc. provides full project management support by assigning a Clinical Project Manger to communicate and manage all study activities. There are 75% of Clinique Research Services, Inc. consultants which have project management experience from previously held industry positions.
Regulatory approval processes differ across countries and product segments. Africa being unique a space, requires the expertise of an Organization that knowledgeable of the terrain and is conversant with the regulatory processes.
Clinique Research presence on ground gives a unique advantage and access.
· We facilitate regulatory support for clinical trial approvals, ethics committee approvals and import/export permits.
· We also provide support for healthcare 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 the study submissions to this bodies for our clients using a streamlined regulatory document collection.
· We help reduce the start-up timeline by providing clear instructions and expectations on how to correctly complete documents and ensure a timely submission, so as to obtain faster approvals.
Types of Regulatory Support We Provide
Advisory & Consultancy Services
Clinique Research provides advisory and consulting services to pharmaceutical and Biotech organizations who are interested in African continent. We help organizations navigate the system so they can meet their goals.
A well-prepared application is key to a successful regulatory approval. We make detailed submissions that ticks-off all the requirements of the regulatory body.
Regulatory Feasibility Assessment
The feasibility of regulatory requirements can save a lot of time and resources in achieving a successful regulatory approval. This will determine if the Client’s product will eventually be approved upon submission.
Pharmaceuticals, biological products such as vaccines and gene therapy are the leading treatment and preventive solutions worldwide. The regulatory application/approvals guidelines needs to be adhered to in other to avoid delays and extension of study timelines.
Nutraceuticals and Supplements
Nutraceuticals, dietary supplements, cosmetics and other complementary medicines form a significant amount of healthcare products globally. Their growing demand has led to a rise in understanding their regulatory approval process.
Physical and supporting devices are some of the most common medical devices used worldwide, due to their diverse uses, marketing authorization process differ from country to country.
For all of the aforementioned, Clinique Research provides support extending from advisory and consulting support to regulatory support for product registrations as well as clinical trial related approvals.
Before preparing an application, perhaps there is need to clarify particular information or provide answers to important questions. We are always available to facilitate meeting between our clients and the regulatory bodies as it applies to specific countries.