PROJECT SOLUTIONS

MF BIOTECH believes in rigorous development strategies and efficient execution. We help innovative biotech and pharma projects with customized and targeted support to meet their goals.

BIOPHARMACEUTICALS & PRODUCT TYPES

  • Protein drugs, monoclonal antibodies, fusion proteins

  • mRNA-based drugs and vaccines

  • Gene therapies, genetically modified organisms (GMOs), genome editing

  • Cellular immunotherapies

  • Regenerative therapies

  • Oncolytic viruses

  • Bacteriophages

  • Small molecules

  • First-in-class therapies

  • Orphan drugs

  • Biosimilars

  • Combination products

We provide our services throughout all development phases, from the idea to product approval and beyond.

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Early Stage

CMC

Nonclinical

Clinical

MAA/ BLA

Post-Approval

Global Development Strategy

We build and execute your product-specific global development strategy from early stage development to product launch. We provide guidance on your functional development plans including all regulatory, CMC, clinical and non-clinical aspects.

    • Preparation of integrated development strategy and definition of key development milestones for CMC, non-clinical, clinical, regulatory

    • Preparation of global regulatory strategy till approval including strategic considerations and requirements for EU and US

    • Assessment of options and scenarios to accelerate product development

    • Target product profile (TPP) definition

    • Competitive landscape analysis and regulatory intelligence

    • Preparation of functional project plans for CMC, clinical and nonclinical develop ready for execution

    • Technical gap analyses incl. proposals for remediation

    • Comprehensive time and budget planning for complete development program

    • Planning of development project scenarios for decision-making 

    • Writing of Biosimilarity assessment report

    • Management of development programs, complex projects, and multi-project portfolios including project planning and tracking of timelines, quality, costs

    • Operational support for clinical trials via CTIS

    • Planning and execution of tech transfer projects 

    • Implementation of project management processes and tools

    • CMO and vendor management

    • Project reporting and performance measurement 

    • Crisis and change management

    • Management of grants and public funding 

Regulatory Affairs

We support you with regulatory and medical writing of your submissions to authorities. We provide flexible and fast hands-on support for your day-to-day operations to get things done on time and where you need it. 

    • Preparation and management of scientific advice meetings and regulatory interactions including meeting request and briefing documentation, organization and management of procedure (EMA, FDA, national competent authorities, Health Canada)

    • Writing and preparation of applications for grants and public funding

    • EU representative and primary contact in all dealings with EMA

    • Preparation of requests for regulatory expedited programs such as PRIME, breakthrough, RMAT designation

    • Preparation of applications for orphan drug designation (ODD) and humanitarian use device (HUD) designation

    • Preparation and management of SME applications to EMA

    • Acting as Interim Regulatory Affairs Professional in your team

    • Writing of investigational medicinal product dossier (IMPD), investigational new drug (IND) applications

    • Writing of Investigator's Brochure

    • GMO documentation for clinical trial applications in the EU, environmental risk assessment (ERA)

    • Writing of marketing authorization application (MAA), biologics license application (BLA)

Let’s work together.

PROJECTS

A selection of our projects, which we are proud of.

EXPANDED CAPABILITIES

Coaching & Workshops

We recognize the complexity of biopharmaceutical development and thus the value of specialized training for professionals. We teach startups, developers, and entrepreneurs how to bring your product development strategy to the next level.

  • Tailor-made coaching and training workshops for biopharmaceutical start-ups, development teams and academia

  • Enable teams with hands-on knowledge and best-in-class tools to establish product-specific development strategy and to execute development plans effectively

  • Address key development issues in areas for CMC, nonclinical, and clinical development

Strategy & Operations Solutions

Our journey together doesn’t have to end once regulatory approval has been attained. We also help pharmaceutical companies navigate the complexities of bringing their products to market and maximizing their commercial success post-approval.

  • Comprehensive market analysis, competitive landscape evaluation, and go-to-market planning

  • Strategic pricing, sales, and distribution planning to optimize market penetration

  • Ongoing pharmacovigilance and safety monitoring to maintain product integrity

  • Supply chain risk management, manufacturing optimization, and quality control enhancements

Scientific Due Diligence

Looking to invest in biopharmaceuticals? Our thorough assessments can help give you confidence in your investment’s scientific and regulatory integrity and deliver the insights and assurance you need to make informed, strategic investment decisions.

  • In-depth evaluation of scientific data, preclinical, and clinical trial findings

  • Identification of scientific, technical, and regulatory risks and development of appropriate risk mitigation strategies

  • Intellectual property review, including patent landscape analysis and freedom-to-operate assessments

  • Strategic comparison with industry standards and competitor offerings

Your partner for all things biotech.

CONTACT US

How can we help you?