Services

PHARMABIO Consulting’s Biotech Consulting

PHARMABIO Consulting excels in the development of BIOSIMILAR MEDICINES and Follow-on Biologics (FOB), staff having led the first biosimilars to the EU market. PHARMABIO Consulting provides expertise covering all key disciplines, having regulatory experts including former FDA and EU regulators, statisticians, clinical pharmacology and clinical efficacy/safety and pharmaceutical experienced consultants.

With global strategy in mind, we can help you with a comprehensive, program for the selection, development and approval of any type of biosimilar product, anywhere in the world.

Our services for drug development include:

• Interpretation of EU and USA and Japan/Korean/Canadian regulations and guidelines
• Science-based strategies for addressing all technical aspects of drug development (labeling, chemistry/manufacturing, preclinical, clinical)
• Planning of pharmaceutical, toxicology and clinical development programs
• Identification and monitoring of suitable and reliable partners to carry out the required development work
• Protocol development and project implementation
• Clinical phase I-IV support
• Paediatric Investigational Plans (PIPs)
• Orphan Drug Designations
• CTAs/INDs and CTD / MAAs / NDAs /BLAs and global GCP/ GMP audits
• eCTD dossier preparation and submission

Our portfolio of regulatory services include:

• Biologics (monoclonal antibodies, ADCs, gene & cellular therapies, proteins, enzymes)
• Peptides, small molecules and macrocycles
• Regulatory authority liaison
• Presubmission evaluation of technical data (chemistry/manufacturing, preclinical, clinical, labeling)
• Determination of regulatory and legal status
• Determination of regulatory strategy for planning, manufacturing, preclinical and clinical development
• Expert reports; quality, non-clinical and clinical overviews and summaries
• Orphan drug development: designation EU/US ODD) , Rare Pediatric Disease (RPD) Designation
• Paediatric Investigational Plans (PIPs)
• Risk Management Plans
• Environmental assessments
• Product information: EU SmPC, PL, Labels; US PI, Labels,
• Document preparation including marketing authorisation applications for drugs
• Submission and follow-up including answering of authorities’ concerns and filing of appeals
• Chemistry/manufacturing, preclinical and clinical consultations, technical reviews and writing