LIFE SCIENCES CONSULTING

Stay Ahead of the Product Development Curve

Life science companies, investors and entrepreneurs must be ready at all times to take on today’s challenges while preparing for those of tomorrow.

Undertaking this complicated journey alone can become daunting and costly. Our consultants will carefully consider all strategies and alternatives during each step of the regulatory process. Whether your end goal is an IND, CTA, NDA (505b1 or 505b2), ANDA, BLA, DMF, 510k, De Novo, IDE or PMA submission, we don’t just help you envision a state of ongoing preparedness, we help you achieve it.

Put Our Decades of Experience to Work for You

By working with Ayd BioPharma Consulting Group, your organization will benefit from decades of expertise drawn from a team of industry specialists and prior FDA officials. Our experts stay on top of the latest industry trends, distilling data and knowledge into insights to help you confidently make informed strategic decisions. We offer support for Big Pharma, mid-tier, biotech, generics and medical device companies, as well as financial investors and law firms.

Our Core Life Sciences Consulting Areas

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

PRECLINICAL SUPPORT & REGULATORY INTELLIGENCE

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

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

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

GO-TO-MARKET / PRODUCT LIFECYCLE

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

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

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.

PARTNERS

Ayd BioPharma Consulting Group offers a full spectrum of consulting services spanning the product development and commercial product lifecycle.

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Picking the Right CRO for You

For many companies, selecting a contract research organization (CRO) can be a stressful task, as it is important to find one that could be your partner throughout the clinical trial process. And given that the time from the start of human clinical testing until a drug is actually approved by regulatory authorities can be anywhere from 10 to 18 years, you could be in for a long-term relationship with a CRO.