Pharmaceutical regulatory affairs refer to the legal and other requirements of the pharmacy practice. It was developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. The art of pharmacy belongs to the regulated field, Thus to know the relevant regulations is the professional life itself.
Pharmaceutical Regulatory Affairs
Jeyflex Consultants shall respond to all your queries and meet all your compliance requirements. If your company needs compliance assistance in Kenya and beyond, please talk to Jeyflex Consultants and learn more about the value our team can bring into your team. Our objective is to provide exemplary quality compliance support; thereby eliminating unnecessary delays in the registration and licensing processes
What is Pharmaceutical Regulatory Affairs?
Our Regulatory Affairs Professionals
Regulatory affairs professionals are key players in this industry and act as a communication link between the industry and the regulatory agencies, in Kenya , the pharmacy and poisons board. Regulatory affairs professionals are charged with the responsibility of ensuring availability of safe, efficacious and high quality drugs to the public. They also ensure rational use of drugs.
Our Key Responsibilities
1. Compliance
Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
2. Collaboration
Working with local regulatory agencies and personnel on specific issues affecting their business. I.e. working with such agencies as the pharmacy and poisons board.
3. Consultation
Advising their companies on the regulatory aspects and climate that would affect proposed activities. I.e. describing the “regulatory climate” around issues such as the promotion of prescription drugs, licensing ETC.
Why work with us?
Due to the changing resources necessary to fulfill the regulatory requirements, some companies choose to outsource or out task regulatory affairs to external service providers. In today’s competitive environment the reduction of the time taken to reach the market is critical to a product’s and hence within the company’s for their success and growth. The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the company.
Customer service shouldn’t just be a department, it should be the entire company.
Tony Hsieh
Interested In Our Regulatory Affairs Services?
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