REGULATORY / QUALITY / IP STRATEGIES
PROCESS & ANALYTICAL DEVELOPMENT, TECH TRANSFER
CLINICAL PROTOCOLS / MEDICAL AFFAIRS
DUE DILIGENCE / IP STRATEGIES
STATE OF THE ART CLINICAL AND BIOPROCESS DEVELOPMENT
BioAptia Consulting offers comprehensive consulting services for the biotech industry focused on all phases of biologics and advanced therapeutics development. Our consultants provide expertise in process development, continuous manufacturing, PAT, regulatory, clinical development, GxP, medical writing with a special focus on advanced therapeutics such as gene & cell therapies.
Broad Medical & Clinical Regulatory (Orphan Drug Apps, RMAT, BTD, PRIME Applications, Briefing Documents, IND Applications, New Drug Applications) and CMC Expertise (Continuous Manufacturing, Integrated PAT, Equipment Design, Pre-Approval Inspections, Quality Documentation) with State-of-the-art Focus on Advanced Therapeutics Such as Gene and Cell Therapies.
Our highly advanced consulting team is able to provide rapid state-of-the art experties in all aspects of Bio Development.
For your convenience immediate remote and on-site services are available. Contact our offices in Burlington to speak with us about helping your team rapidly develop novel biotechnology products.