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Services

Regulatory & Quality

Biologics

Explore our wide range of Biologics related services, which will help you stay compliant with existing and changing regulatory and quality requirements.

    Regulatory

    Partner with us to seek approval and meet the extensive requirements in the Code of Federal Regulations (CFR) to begin clinical testing and to market a biologic product.
  • Learn More
    • Investigational New Drug (IND) or Device Exemption (IDE)
    • Biologics License Applications (BLA)
    • 510(k)
    • Pre-Market Approval (PMA)
    • New Drug Application (NDA) Process
    • Abbreviated New Drug Application (ANDA) submission
    • Orphan Drug Designation (ODD)
    • Clinical regulatory expertise for products in all stages of clinical development
    • Interfacing with industry experts and regulatory authorities
    • Building or refining Regulatory Strategy
    • Represent clients in interactions with FDA
    • Assist with preparations for FDA and Advisory meetings
    • Provide clients with a review of submissions
    • Advice on regulatory options and potential pathways
    • Project Management
  • Quality

    We assist in developing integrated quality systems incorporating US ICH cGMP requirements. Quality systems are imperative for compliance
  • Learn More
    • ISO 9001 certification
    • GxP (GMP, GCP, & GLP) compliance
    • Designing, implementing and optimizing GxP quality system
    • Quality systems implementation, remediation and improvement
    • Internal audit and report
    • Supplier audit and report
    • Audit
    • Current Good Tissue Practice compliance
    • Clinical quality compliance audits, including Good Clinical Practices (GCP) and pharmacovigilance (PV) audits
    • Standard operating procedure (SOP) development for clinical testing
    • Project Management
  • Product

    We help you identify and consolidate all the product documents needed for getting a regulatory approval based on the target country’s specific requirements.
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    • Current Good Tissue Practice compliance
    • Product development plans
    • Tissue facility registration
    • Animal testing
    • In-vitro testing
    • Product specific testing
    • Project Management
  • Clinical

    Every biologic product has a clinical application and to bring the product to the market and keep it there, clinical documents are of primary importance.
  • Learn More
    • Clinical gap analyses and due diligence assessments
    • Clinical trial consulting, design and protocol development
    • Trial master file creation and maintenance support
    • Project Management

Overview

A complete solution for all regulatory and quality systems requirements for Medical Device, Drugs and Biologics companies. Our dedicated team of experts have the right skills and tools at their disposal to quickly bring your product to the market. Let us take care of regulations, so you can focus on what you do best.

Testimonial

Elexes team gave our organization great support. Apart from being knowledgeable, and thorough; they were very responsive. All these are excellent virtues which I would look for when choosing a consulting firm.

Tom Birney
CEO, Masterlink
Phoenix,AZ

Elexes should be your next regulatory consultant. A timeline based project plan from their part greatly expedited the process.

Huiyou Zhu
CEO, TrioWave
Fremont, CA

Elexes promised and delivered - a go-to organization for FDA regulatory and quality systems work. They have outperformed every expectation we had.

Kurt Sysock
CEO, Radformation
New York

They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports, and provided advice on testing and manufacturing. They are very professional and easy to work with.

Daniel Kinsey
President,ViDava
Sarasota, FL

We worked with Elexes on import-export regulations, and couldn't have asked for a better expert. Elexes team was very patient in answering all our questions, and guided us on every step. Will definitely work with them again!

Linda Pan
Sr. Exe, Treedental
Hong Kong

They are prompt and responsive and have done a great job with our regulatory projects and document control set-up. They were easy to contact and were quite quick at understanding the nuances of our product. I highly recommend them!

Michal Depa
CTO, Jana Care
Boston, MA

Elexes team are always most helpful and proactive. They are thorough and have provided invaluable support to us on import, labels and registrations.

Philip McFerran,
MD, Blackrock Pharma
Slough, UK

Created regulatory compliant supplement fact sheets for multiple products. Very happy with the work. They were accurate and the turnaround time was amazing.

Elizabeth W.
Owner, Liz Inc.
Phoenix, AZ



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Contact Us

E-mail : jennifer@elexes.com
US Phone Number : +1-408-475-8091
Indian Phone Number : +91-7899544400

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