Empowering Your Path to Innovative
Therapeutic Success

Expert Consultancy from Preclinical to Clinical Success for Biotech and Pharma Companies

Who We Are

With over a decade of global experience, we support biotech companies in navigating the complexities of drug development programs.

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Our Services

Preclinical Development Plan and Studies

We provide support for planning preclinical studies (Efficacy, pharmacology, toxicology and safety), covering study design, vendor selection and management, and completion of the IND/CTA-enabling data package.

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Biomarker and Bioanalytical Support

We provide guidance in establishing biomarker and bioanalytical methods (PK/PD/Immunogenicity) for your therapeutics compound (small or large molecule), including data review and reporting support.
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CRO Selection and Contract Negotiation

We assist in identifying and selecting the right CRO or CMO, as well as reviewing Master Service Agreements, optimizing study design, and managing vendors to ensure high-quality data
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Biotech Management Consulting

We provide support for Project and portfolio management with timeline optimization, financial planning and resource allocation as well as Stakeholders management and communication

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Biotech Strategy Consulting

We offer strategic guidance to early-stage biotech companies, offering development roadmaps, feasibility studies, proactive risk assessment and mitigation strategies to ensure successful project execution.

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Due Diligence

We offer a Due Diligence service to evaluate the accuracy and completeness of preclinical, Clinical and bioanalytical data packages for regulatory submissions and scrutiny of data room management for licensing deals.
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Clinical Development Planning

We assist in  trial design, clinical feasibility studies, biomarker and bioanalytical studies (PK/PD/Immunogenicity), vendor and data management; and regulatory submissions (IND/CTA).
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Regulatory Support

We help with regulatory strategies, EMA and FDA interactions (e.g., SA, PA, pre-IND, and Type C meetings), and support regulatory documentations (IB/IMPD), and orphan drug designation (ODD) submissions.

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10+years of service
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Why Choose Us

  • Extensive global experience in biotech project management.
  • Proven success in preclinical and clinical development strategies.
  • Expert guidance in navigating FDA and EMA regulatory requirements.

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Partner with Us for Biotech Success

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