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
- Start-up companies finishing pre-clinical safety/tox work and moving into the clinical stage (First-in-human studies)
- Established Pharmaceutical Companies
- Pharmaceutical Drugs 505(b)(1) & 505(b)(2) “NDA”
- Generic Drugs 505(j) “ANDA”
- Companies Developing “FDA-Regulated” Novel Cannabis-Derived Drugs
- Biologics/Biosimilar Companies
- Cellular and Gene Therapy (CGT) Companies
- Pharma and Biologic Companies involved in Research and Drug Development for:
- Orphan Designated Drugs 21 CFR Part 316
- Rare Diseases
- Pediatric Indications (Voucher)
- Medical Device Companies
- Combination products
- “510k to ANDA” Switch
- Financial Investors (individual or institutional)
- Law Firms
- Contract Development and 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
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 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
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
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
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’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.