Empowering BioPharma Success Through Innovation
Scientifically Tailored, Swiftly Delivered
Innovation drives the future, and BioPharma Innovation Services (BIS) partners with you at every step—supporting pipeline development, global clinical programs, and regulatory strategy. Acting as a catalyst between your scientific team and regulatory agencies, BIS helps accelerate the registration of advanced new products. Our experts are seasoned professionals from leading global pharmaceutical and biotech companies, with a proven track record of registering NMEs, medical devices, biosimilars, cell and gene therapies, diagnostics, and complex generics/505(b)(2) products across major markets, including the US FDA, EMA, MHRA, PMDA, ANVISA, COFEPRIS, CDSCO, Health Canada, J-FDA, and more.
Our scientific advisors, key opinion leaders (KOLs), and global network provide strategic consultation to support your pipeline development. They offer scientific oversight and vigilance throughout the product lifecycle—from early-stage development through regulatory registration and beyond. Below are the core scientific service domains we offer
Pipeline Building Services
BIS connects established pharmaceutical companies with start-ups, small to mid- size pharma/biotech firms, and academic innovators to access novel early-stage assets and technologies. We actively scout for promising products suitable for in- licensing, acquisition, or geographic expansion to strengthen your pipeline. BIS also facilitates co-development partnerships—enabling shared risk, faster timelines, and combined expertise.
Our support extends to technical due diligence, offering comprehensive scientific, clinical, and regulatory assessments of potential assets. Backed by a global infrastructure, BIS enables cross-border development, clinical trial execution, and international expansion.
Global Clinical Development Strategy Services
BIS designs and executes global clinical trial strategies across all phases, with a strong emphasis on scientific rigor and regulatory compliance. Our clinical-regulatory strategy is tailored for global markets, aligning with the requirements of agencies such as the FDA, EMA, ANVISA, MHRA, Health Canada, and others.
Through our Technical Development Services (TDS), BIS offers:
Regulatory Agency Engagement – Including pre-IND/IMPD meetings and
scientific advice to ensure early alignment with health authority expectations.- Global IND/CTA Planning and Submissions – Managing multi-region filings
and ongoing regulatory interactions efficiently.
- Region-Specific Protocol Optimization – Customizing protocols to meet
diverse clinical and regulatory requirements across target countries.
- Dossier Preparation and Submission Support – Covering eCTD
publishing, response to health authority queries, and comprehensive
regulatory writing.
Cell & Gene Therapy Services
BIS offers full-spectrum scientific services to support the development of cell and gene therapies across all stages. Our services include:
- CMC Support – Consulting on process optimization, product characterization,
and lot-release specification review. We also assist in GMP set-up and
provide access to ready-to-use vectors for biotech companies seeking co-
development partnerships.
- Preclinical Safety & Efficacy – Guidance on in vivo and in vitro studies,
including tumorigenicity, biodistribution, and potency testing, to build robust
FDA/EMA submission packages.
- Clinical Trials – Execution of Phase I–III clinical trials, supporting your
journey from lab to bedside. We offer access to hospital partners with GMP
infrastructure ready for immediate clinical development.
- Patient Follow-Up Programs – Implementation of long-term monitoring
programs to track delayed adverse events, critical for gene therapy products.
- Global Regulatory Strategy – Acting as your scientific partner for meetings
with global health authorities such as the FDA, EMA, MHRA, and others.
Medical Device Services
TechObserver has successfully conducted numerous medical device clinical trials. Building on this expertise, BIS now offers advanced scientific services tailored for medical devices:
- Human Factors Clinical Studies – Execution of formative and summative
studies involving real users at affiliated hospital settings, along with IFU
(Instructions for Use) review and updates.
- Clinical Strategy & Study Design – Applied trial design strategies focused
on efficacy, safety, usability, or pharmacokinetics, followed by full study
execution.
- Clinical Evaluation Reports (CERs) – Comprehensive gap analysis and
updates of CERs to ensure alignment with EU MDR and IVDR requirements.
- Post-Market Surveillance (PMS) – Development of proactive risk
management strategies and PMS plans to ensure ongoing global regulatory
compliance.
Diagnostics Services
With TechObserver’s extensive experience in clinical trials for diagnostics, BIS now offers expanded scientific services to support diagnostics development and commercialization:
- Clinical Utility Studies – Generation of real-world evidence demonstrating
the diagnostic’s impact on patient outcomes, including the design and
execution of applied clinical studies.
- Regulatory Submissions – Acting as a scientific partner for engagements
with global regulatory authorities such as the FDA, EMA, MHRA, and others,
supporting strategy and submission readiness.
- Digital Health Integration – Validation of AI/ML-based diagnostic algorithms
and ensuring compliance with regulatory requirements for software-as-a-
medical-device (SaMD).
Biosimilars Services
Since 2009, BIS experts have been deeply experienced in the clinical development and global registration of biosimilars. Our Biosimilars Center of Excellence provides comprehensive end-to-end services, including:
- Biosimilarity Consultation – Detailed review and analysis of analytical, in
vitro, and in vivo biosimilarity data.
- Clinical Strategy Consultation – Optimized, cost- and time-efficient clinical
strategies tailored to country-specific or global regulatory pathways.
- Biosimilarity Studies – Conducting in vitro (PD biomarker assays), Phase I
(PK-PD-ADA) trials in healthy subjects or patients, and Phase III efficacy and
safety trials as global or local studies.
- Regulatory Pathway Optimization – Expertise aligned with EMA, FDA,
WHO, and other major guidelines, acting as a scientific partner for meetings
with FDA, EMA, PMDA, MHRA, Health Canada, and others.
- Immunogenicity Risk Assessment – Customized strategies to evaluate and
mitigate immunogenicity risks throughout development.
- Post-Market Monitoring – Pharmacovigilance and real-world evidence
(RWE) generation to ensure long-term safety and compliance.