OUR SERVICES
Your success is our success
The BrevisRefero team is a collection of bio-based technology consultants who share a common goal - to improve and support the management of biologics programs from concept to development, GMP manufacturing, and into clinical trials.
We help our clients successfully deliver their large molecule drug products in support of Phase I-III human clinical trials by using our extensive Contract Development & Manufacturing Organization (CDMO) experience to effectively and efficiently manage their complex third-party service provider relationships.
Our comprehensive biotech consulting services include:
Business Operations
• Corporate strategy and value creation • Capital formation and investor relations • CMC technical due diligence • Alliance management and strategic growth • Startup governance • Innovation management
Technical Operations
• Request for Proposal (RFP) management • Technical program management • Technology transfer planning and execution • Oversight of process and assay development and optimization activities • Bioprocess troubleshooting and investigations Managing scale-up, engineering and GMP manufacturing operations External clinical and commercial manufacturing • Auditing, compliance oversigtht, and regulatory submission support • Facilities design and conceptual engineering
Commercial Operations
• Due diligence, product vetting and overall business management support • Managing of complex virtual service chains on behalf of sponsor companies • Business development, marketing and sales • Product development roadmaps • Clients’ portfolio management • E-Technology development, programming, and coding custom application solutions for biopharma applications
Clinical Operations
• Clinical project management and supporting activities • Coordination of cross-functional clinical and regulatory team meetings • Compliance management • Oversee study start-up activities • Study progress monitoring • Status update reports to senior management and sponsors • Manage study documentation • Ensure accuracy and completeness of study data • Oversee data management activities • Facilitate study close-out activities • Maintain effective relationships with study sponsors, agencies, and stakeholders