Product Development & Regulatory Affairs
History
The Department of Product Development and Regulatory Affairs (PD &RA) was set up in 2003, as a result of a large order made by an international distributor, for branded products in the Francophone ECOWAS sub-region. A team of professionals was put together to look at the work of branding and the need to extend work on brands, and at the same time embarking on ISO Certification. It started as a section and developed into a full Department, engulfing Regulatory and Pharmacy Affairs and Pharmacovigilance. The Department is involved in Development, evaluation, Reviews, and Regulatory filings and submissions.
The Department develops the following category of dosage forms: Hard Gelatin capsules; Dispersible tablets; Dry powders in sachets and bottles; Coated and uncoated Tablets; Syrups and suspensions; Blister Co-packaging; Pediatric combination packaging; Encapsulation of powders. The role of the Product Development and Regulatory Affairs (PD & RA) Department is to sustain the business of the Manufacturing and Distribution of Phyto-Riker’s Products by; Meeting Regulatory requirements; Development of New Products and Reformulation or Modifying existing ones to meet market needs; Providing Technical Support in all areas of operations, and carrying out Pharmacovigilance activities.
It also offers services such as; Contract development of Formulations for other companies, and also works in collaboration with institutions like USAID to produce Products for other National programs. It is also into Generics, Packaging design, and promotional materials, made in-house. The key objective of the Department is to; Carry out an update of the regulatory requirements of the various countries/organizations, where the company’s products are registered or intended to be registered and to meet schedules in respect of new product registration as well as renewals.
PD & RA is poised to ensure continuous Total Quality Management, WHO GMP compliance, as well as having WHO Pre-Qualification Products, and to sustain the business of providing quality medicines in the ECOWAS region and beyond. Through PMAG and WAPMA, we obtain technical assistance from UNIDO, WAHO, WHO, and USP/PQM. Our Regulators are; FDA, NACOB, Pharmacy Council, NAFDAC, and other NMRAs in the ECOWAS region. We collaborate with SHOPS/USAID. PD & RA -THE DEVELOPER OF PHYTO-RIKER…..FOREVER.