What are the opening hours?

Monday 09:00 - 17:00 Tuesday 09:00 - 17:00 Wednesday 09:00 - 17:00 Thursday 09:00 - 17:00 Friday 09:00 - 17:00

Evka Consultz Ltd

Home
Kenya
Nairobi
Evka Consultz Ltd

We are a pharmaceutical regulatory affairs services company.

23/06/2025

Looking to register your pharmaceutical products and obtain Marketing Authorization in Kenya or the East African Community (EAC)? At EVKA, we specialize in tailored, cost-effective solutions for pharmaceutical regulatory affairs.

Here’s why clients choose us:
✔️ Deep understanding of local and regional regulatory requirements
✔️ Efficient registration support through trusted regulatory pathways
✔️ Faster market access through streamlined processes
✔️ Full-spectrum services: marketing authorization, licensing, lifecycle management, trade permits, pharmacovigilance, audits & training

Get your products to market—on time and in full compliance.
📞 Contact us today at +254 732 451 324

https://evka.co.ke/

hashtag hashtag hashtag hashtag hashtag hashtag

11/06/2025

Pharmaceutical regulatory compliance plays a critical role in safeguarding public health by ensuring that every medication brought to market is safe, effective, and of the highest quality. From rigorous testing to stringent approvals, these standards protect patients and promote trust in healthcare systems.

✅ Why It Matters:

Prevents harmful side effects and unsafe drugs.

Guarantees medication efficacy for better health outcomes.

Builds confidence in the healthcare and pharmaceutical industry.

Let’s collaborate to uphold these vital standards and prioritize patient safety at every step!

hashtag
hashtag
hashtag
hashtag

06/06/2025

May this Eid bring peace, blessings, and joy to you and your loved ones. Eid Mubarak to all Muslim faithful

03/04/2025

Staying compliant with pharmaceutical regulations is key to ensuring smooth approvals and market access. Here are two essential tips:

✅ Stay Updated on Regulatory Changes – Regulatory frameworks are constantly evolving. Regularly reviewing updates from authorities such as the FDA, EMA, or local regulatory bodies helps you anticipate changes and avoid potential delays in the approval process.

✅ Engage with Local Regulatory Authorities – Building strong relationships with regulatory agencies can streamline compliance. Engaging early in the process, seeking guidance, and maintaining open communication can help resolve challenges before they become roadblocks.

Proactive compliance not only accelerates approvals but also builds trust in your pharmaceutical products.

📞 For help with regulatory compliance in Kenya and the larger East Africa, reach out to us at +254732451324.

03/03/2025

In the pharmaceutical industry, audits play a critical role in ensuring compliance, quality, and safety. Understanding the different types of pharmaceutical audits can help organizations maintain high standards and meet regulatory requirements. Here are the key types of audits you should know about:

☑Internal Audits: These are conducted by the company’s own staff to evaluate the effectiveness of its internal controls, processes, and systems. Internal audits help identify areas for improvement and ensure compliance with internal policies and procedures.

☑External Audits: These are performed by independent third parties to provide an objective assessment of a company's compliance with regulatory standards and industry best practices.

☑Regulatory Audits: Conducted by regulatory authorities, these audits ensure that pharmaceutical companies comply with applicable laws and regulations. Regulatory audits are essential for product approvals and market access.

☑Supplier Audits: These audits assess the quality and reliability of suppliers and their products.

☑Customer Audits: Customers, especially large pharmaceutical companies, may audit their contract manufacturers or service providers to ensure they meet the necessary quality and regulatory standards.

☑For-Cause Audits: These are targeted audits initiated in response to specific concerns or issues, such as product recalls, quality defects, or compliance.

By understanding and effectively managing these different types of audits, pharmaceutical companies can ensure compliance, improve processes, and maintain high standards of quality and safety.

20/02/2025

A package insert is a legal document that must be approved by regulatory authorities before it can be distributed with the medicine. The pharmaceutical company that manufactures or markets the medicine is responsible for preparing and updating the package insert according to national requirements. The package insert must be clear, accurate, and consistent with scientific evidence.

Important elements to be included in a package insert are:

1⃣Drug name and dosage form
2⃣Active ingredients and their strengths
3⃣Indications and usage
4⃣Dosage and administration instructions
5⃣Contraindications
6⃣Warnings and precautions
7⃣Adverse reactions
8⃣Drug interactions
9⃣Use in specific populations (e.g., pregnant women, children)

✅Among others...

If you need help with this process, contact us as we specialize in the preparation of package inserts.

Call +254732451324
Website: www.evkaconsulting.com

17/02/2025

Are you looking to register your pharmaceutical products and obtain Marketing Authorization in Kenya or the East African Community (EAC)?

Evka is your trusted partner for navigating Pharma regulatory affairs with ease and efficiency.

Here’s why you should choose us:
1️⃣ Cost-Effective & Timely Solutions: We streamline the regulatory process to save you time and money.
2️⃣ Expert Knowledge: Our team has a deep understanding of both local and regional regulatory requirements.
3️⃣ Optimized Processes: We work to enhance the efficiency of product registration with regulatory authorities.
4️⃣ Fast Market Access: We help you get your products to market in record time.

Let us handle the complexities so you can focus on innovation and growth.

13/02/2025

As a Pharmaceutical regulatory consulting company, we help our clients understand the regulatory process and develop strategies to meet the challenges of pharmaceutical regulation.

Whether you are launching a new product or considering entering a new market, we can provide you with advice on how to best approach your market access strategies.

We provide comprehensive regulatory consulting services to pharmaceutical companies within East Africa.

Call +254732451324 for more information

10/02/2025

Pharmacovigilance is all about ensuring the safety and efficacy of medicines. Here are some crucial aspects of pharmacovigilance that everyone in pharma should know:

1️⃣Adverse Drug Reactions (ADRs)
Monitoring and reporting any adverse reactions to medications is vital for patient safety. This helps identify new risks and improve drug safety profiles.

2️⃣Reporting Systems
Healthcare professionals and patients should utilize reporting systems to document any side effects or unexpected reactions. This data is crucial for regulatory authorities to take necessary actions.

3️⃣Risk Management
Implementing risk management plans helps to minimize potential risks associated with drug use. This includes regular safety updates and communication with healthcare providers.

4️⃣Post-Marketing Surveillance
After a drug is approved, continuous monitoring is essential. This helps in detecting any long-term or rare adverse effects that might not have been evident during clinical trials.

5️⃣Patient Education
Educating patients about the importance of reporting side effects and understanding their medications can lead to better health outcomes and improved safety.

Sharing data and collaborating with international regulatory bodies helps in understanding global safety issues and improves the overall pharmacovigilance system.

07/02/2025

Marketing authorization plays a critical role in safeguarding public health. It ensures that medical devices meet stringent safety, effectiveness, and quality standards before they reach healthcare facilities and patients.

This comprehensive process involves:
✅ Rigorous testing to validate device performance
✅ Compliance with international and local regulatory standards
✅ Continuous monitoring for safety and effectiveness post-market

By preventing the use of untested or substandard products, marketing authorization builds trust in healthcare solutions, protecting both patients and practitioners. It's a cornerstone of advancing safe and innovative medical care.

22/01/2025

Ensuring better health outcomes goes beyond the initial approval of medications. Post-approval monitoring is a critical pillar of pharmaceutical regulation, safeguarding public health by continuously assessing the safety, efficacy, and quality of medicines long after they reach the market.

Through rigorous surveillance, real-world data analysis, and adverse event reporting, regulatory bodies can identify potential risks, update safety guidelines, and enhance treatment outcomes. This ongoing vigilance ensures that every patient receives the most reliable and effective therapies available.

20/01/2025

In the pharmaceutical industry, process validation is a critical step in ensuring that every product meets the highest standards of safety, efficacy, and quality. It’s not just about compliance—it’s about protecting patient health.

Why is Process Validation Important?
✅ Ensures consistent product quality across batches
✅ Reduces risks of contamination and variability
✅ Enhances regulatory compliance with FDA, EMA, & WHO standards
✅ Improves manufacturing efficiency and reduces waste

By validating every step of the production process, pharma companies guarantee that each dose is as safe and effective as the last because in medicine, there’s no room for error.

Address

Hse No 52, Marurui Estate, Next To Marurui Police Post, Off Northern Bypass, Ushindi W Lane
Nairobi
19528-00202

Opening Hours

Monday	09:00 - 17:00
Tuesday	09:00 - 17:00
Wednesday	09:00 - 17:00
Thursday	09:00 - 17:00
Friday	09:00 - 17:00

Telephone

+254732451324

Website

http://www.evkaconsulting.com/

Alerts

Be the first to know and let us send you an email when Evka Consultz Ltd posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Contact The Practice

Send a message to Evka Consultz Ltd:

Want your practice to be the top-listed Clinic in Nairobi?