A Global Consulting Company
yyissa@pharmaligent.com

We help companies re-mediate and maintain regulatory and quality compliance in an ever-changing environment. View our Services.

Pharmaceutical quality

Quality Systems

We provide global Quality and Compliance consulting services to develop programs and compliance processes that promote continuous improvements to productivity and quality.

Risk Assessments

Our methodology and therapeutic foresight leads our customers to more confident, compliant drug and device development and manufacturing decisions.

FDA Response and Resolutions

We provide independent consulting that is proven, results-driven, and with excellent communication in the FDA-regulated industry.

Frequently asked Questions

We have over 20+ years of experience providing expert regulatory and quality advice for the pharmaceutical and biotech industries. Our consultants bring decades of industry expertise in driving our quality approach, process development, and remediation advice. The committee ensures our solutions are best in class, combining substantiated research with the most effective quality tools available today. 

We provide global Quality and Compliance consulting services to develop programs and compliance processes that promote continuous improvements to productivity and quality.  We target the specific needs of the pharmaceutical, medical device and biologics industries. 

Yes.  Pharmaligent provides SMEs for Resolution of Quality Assurance matters and Quality Systems / Programs that sustain GxP compliance in companies in the US, Europe, Asia and Africa.

Key Advantages

Competent

We have over 20 years experience providing expert quality and regulatory advice.

Passionate

A young, enthusiastic team of industry professionals are always here to help.

Experts

Our pharma/biotech specialists ensure you get the optimum results for your FDA-regulated products.

What we can do for you

Pharmaligent is tuned with  the current trends of the industry, as well as the needs of companies developing pharmaceuticals, biologics, combination products and medical devices. We understand the requirements for compliant development and approval in the US, EU, Asia and Africa. When you contact with Pharmaligent, your message will not be lost because we speak your technical language in both English and French settings. We have the expertise to assist you in navigating the development process while delivering the quality support you expect.

  • We support customers with International Quality Assurance Consultancy and Remediation of FDA 483 observations and Warning Letters
  • Pharmaligent provides SMEs for Resolution of Quality Assurance matters and Quality Systems / Programs that sustain GxP compliance in companies in the US, Europe, Asia and Africa.
  • We support clients with French speaking  Consultants in the US and abroad

Our Clients

wyeth
Avedro
Bluebird Bio
Alexion

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Would you like to speak to one of our advisers over the phone? Just submit your details and we’ll be in touch shortly. You can also simply email us (yyisa{at}pharmaligent.com) if you would prefer.

For Businesses: Do you have questions about how Pharmaligent can help your company? Send us an email, or use our contact form.

Note: Your details are kept strictly confidential as per our policy.

For expert quality and regulatory advice you can trust Pharmaligent