Who We Work with

Ayd BioPharma Consulting Group offers a full spectrum of consulting services spanning the entire product lifecycle to numerous types of organizations.

With pressure on for you to be “smarter than your competitors” to stay current on “rapidly evolving technological advances” and to remain aware of and comply with “frequently changing regulations,” you might think the “goal posts” keep moving. This is why you need expertise and tried-and-true experience at your disposal. Ayd Group is here to provide services spanning the entire product lifecycle to numerous types of organizations.

Our Clients Include

  • Early-stage companies finishing up pre-clinical work and looking forward to clinical stage
  • Pharmaceutical Companies
    • Pharmaceutical Drugs 505(b)(1) & 505(b)(2) “NDA”
    • Generic Drugs 505(j) “ANDA”
    • Orphan Designated Drugs 21 CFR Part 316
  • Novel Cannabis-Derived Drugs “Regulated prescription-only”
  • Biologics/Biosimilar Companies
  • Medical Device Companies
    • Combination products
  • Financial Investors (individual or institutional)
  • Law Firms
  • Contract Development & Manufacturing Organizations (CMOs or CDMOs)

LET OUR NETWORK BE PART OF YOUR NETWORK

A service organization is only as good as the network of experts they build. Meet some of our closest colleagues serving the life sciences community.

Our Core Life Sciences Consulting Areas

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CMC STRATEGY

“Stage-appropriate” technical support for each phase of development from first-in-human clinical trial material through optimized finished drug product for commercial approval. LEARN MORE
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PRECLINICAL SUPPORT & REGULATORY SCIENCE

Preclinical support benefits early-stage companies that need help managing the complexities and uncertainties in translation of preclinical/nonclinical (toxicology) data to justify the starting point for first-in-human studies. Life science companies at all stages of development and of all sizes benefit from regulatory science. Ayd Group stays abreast of the FDA’s Regulatory Science Innovation Initiatives to protect and promote public health. We know where to go to determine how you might benefit. LEARN MORE
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CLINICAL DEVELOPMENT & REGULATORY AFFAIRS

Every new drug or device is different, and each clinical development plan must be carefully thought out and planned for its intended purpose.  Regulatory strategy must be developed with clinical outcomes in mind and should be able to flex as more and more information about safety and efficacy is learned. When both are done in parallel, this leads to the best pathway forward towards eventual FDA approval. LEARN MORE
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QUALITY & COMPLIANCE

Translation of regulatory guidance into proactive and preventative procedures to get your company off on the right track from the beginning. LEARN MORE
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PRODUCT LIFECYCLE MANAGEMENT

Along with FDA approval for a drug or device comes a myriad of post-approval commitments the company must keep. Most notable among them is to inform the FDA of post-approval changes. We help our clients understand the magnitude of impact that a change can have and help them strategize on how to manage any regulatory implications that result. LEARN MORE
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DUE DILIGENCE

When a company decides to grow its drug or device product portfolio, they can either develop the product internally or acquire it in a shorter time by going the M&A route. We help in situations like this by impartially conducting a full-fledged due diligence evaluation to assess risk before you make your decision. LEARN MORE

“I have enjoyed working with you all these years. I have benefited from your deep and vast knowledge. We will continue to work together for the foreseeable future.”

CEO, PHARMA CLIENT

“The partners who worked with me to scope the projects are the same people who lead the projects. Having the same dedicated and experienced team the whole way through makes Ayd Biopharma Consulting Group stand out from the rest.”

CHIEF SCIENTIFIC OFFICER, BIOTECH COMPANY

“I had the pleasure to work with Sharon Ayd and others in Ayd Biopharma Consulting Group who worked side-by-side with me to scope out a custom training program for our sales and marketing team. Some of them are technical, but all benefited from a hands-on GxP training which was done by Sharon and another colleague. It is about four months later, and I definitely see the benefits.”

CEO, STRATEGIC CONSULTING SERVICES COMPANY

“Our Law firm had a request to structure a payer/provider contractual research agreement and we needed a deep subject matter expert in 21CFR 210, 211 and 212. We heard about the Ayd Biopharma Consulting Group and contacted them. We received the assistance needed to draft what turned out to be several very complicated agreements. The ease with which the Ayd Group was able to translate regulations into understandable language was impressive.”

PARTNER, LAW FIRM

Let’s Get Your Organization on a Steady Path to Success Together.

From proof-of-concept to full commercialization and exit, our organization help yours each step of the way.

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