Everlynne Mainnah

Everlynne Mainnah Email and Phone Number

Regulatory Affairs Director at Evka Consultz Ltd @ Evka Consultz Ltd
Marurui Police Post, Gate 52,Kenya
Everlynne Mainnah's Location
Kasarani, Nairobi County, Kenya, Kenya
About Everlynne Mainnah

 Oversee training of teams in GxPs and current Regulatory practises. Licensing- Successfully ensured timely submissions and follow up to approval for Marketing Authorizations, Lifecycle management, including Licence renewals , Label updates and Pharmacovigilance. 17 years’ experience in the Drug regulatory field, with a good network across the Sub Saharan Africa (SSA) Region Sound track record in the registration of various health products and technologies (Human and Veterinary) across the SSA Region GxP consultancy- GMP, GDP, GRP and GPvP, including Audits in these areas. Providing Startegic leadership, Managing both internal and external stakeholdersProviding Reg Intel on latest trends across the SSA region Successfully managed Key projects for various Principals.

Everlynne Mainnah's Current Company Details
Evka Consultz Ltd

Evka Consultz Ltd

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Regulatory Affairs Director at Evka Consultz Ltd
Marurui Police Post, Gate 52,Kenya
Website:
evkaconsultz.com
Employees:
18
Everlynne Mainnah Work Experience Details
  • Evka Consultz Ltd
    Director Quality Assurance Regulatory Affairs
    Evka Consultz Ltd 2007 - Present
    Nairobi
    • Registration of Pharmaceutical products, Veterinary products, medical devices, herbals, vaccines, radiopharmaceuticals and biologics for Kenya, Uganda, Tanzania, Ethiopia Rwanda and Zambia .• Product Lifecycle management (Product Renewals, Retentions and Variations/ Notifications)• Listing of food supplements, Borderline products• Licensing and Advertisement approvals• Report writing and communication with Principals on Regulatory matters.• QMS setup and implementation. Training of staff on the same in line with GxP regulations.• Submission and follow-up on import/ Export permits at the Pharmacy and Poisons Board.• Follow up on lab analysis of products at the pre-qualified labs.• Oversight of the PV system and all PV activities for the products for which the principal holds a Marketing Authorization. (QPPV)• GxP Audits and Manufacturing site setups• Regulatory intelligence
  • Astrazeneca
    Senior Regulatory Affairs Manager Ssa
    Astrazeneca Jan 2023 - Jun 2023
    Nairobi County, Kenya
    • Registration Planning and Business support• Implementation of GRP standards in the SSA Hub • Ensuring timely performance of regulatory processes including Marketing authorizations, Lifecycle maintenance, License renewals and Pharmacovigilance activities• Building and maintaining relationships with key internal and External stakeholders to maintain visibility and accessibility.• Local process expert of the Global labelling Business Process.• Training and Development • QPPV Kenya• Strategic Leadership
  • Bd
    Regulatory Affairs Specialist
    Bd Apr 2022 - Sep 2022
    Kenya
    • Securing Marketing Authorization for medical devices for East African Market• Product lifecycle management (Renewals, retentions and variations)• Liaising with the Business units in budgeting for products, preparation of product dossiers.• Updating of reports on shared platforms and sharing the same with Marketing team • Communication of any product quality complaints or reported adverse effects with product use to the Business unit heads and ensuring any Field safety actions are communicated with the Health Authorities.
  • Sanofi
    Regulatory Affairs Consultant
    Sanofi Dec 2021 - Mar 2022
    Kenya
    - Report writing and communication with principals on regulatory matters.- Securing Market Authorization transfers and product obsoletion in different markets- Product Life cycle management- variations

Everlynne Mainnah Education Details

Frequently Asked Questions about Everlynne Mainnah

What company does Everlynne Mainnah work for?

Everlynne Mainnah works for Evka Consultz Ltd

What is Everlynne Mainnah's role at the current company?

Everlynne Mainnah's current role is Regulatory Affairs Director at Evka Consultz Ltd.

What schools did Everlynne Mainnah attend?

Everlynne Mainnah attended Purdue University - The Graduate School, University Of Nairobi.

Who are Everlynne Mainnah's colleagues?

Everlynne Mainnah's colleagues are Brian Omondi, Michelle Mulwa, Eunice Kireru, Rebecca O..

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