Contact a Biologics Regulatory Expert

Biologics Experience

MCRA’s team of experts has successfully navigated hundreds of US FDA submissions ranging from 510(k)s to PMAs involving advanced first-in-class medical devices. 

MCRA is a world-class provider of regulatory strategy and advice for biologics, combination and biologic related devices, including: 

•    Allografts and demineralized bone matrix products

•    Autografts

•    Bone cement

•    Bone Morphogenic Proteins (BMP)

•    Bone substitutes

•    Cartilage repair systems

•    Growth Factors

•    Hyaluronic acid

•    Orthobiologics

•    Platelet concentration

•    Resorbable fixation devices

•    Scaffold devices

•    Soft tissue and tendon grafts

•    Stem cells

•    Surgical glues

•    Surgical sealants

•    Synthetic cartilage

•    Xenografts

US Regulatory Services

MCRA has industry leading specialization in the full spectrum of orthobiologics, and musculoskeletal related biologic and combination devices, with strong regulatory and scientific leadership offering deep expertise.

Our comprehensive regulatory services include: 

•    Global and US regulatory strategy

•    Regulatory landscape assessment

•    Gap analysis

•    Investigational Device Exemption (IDE)

•    De Novo

•    510(k)

•    Premarket Approval (PMA)

•    FDA appeals

•    FDA training

•    FDA warning letters and 483 observations

•    Pre-clinical testing plan

•    Clinical testing plan

•    Due diligence services

•    Agency interaction

•    Device classification

•    Import/export

•    Labeling

•    FDA meeting strategy

•    Real-time reviews

•    Device listing

•    Establishment registration

•    Regulatory file letters

•    Medical device reporting

•    IDE Reporting

Contact a Biologics Regulatory Expert