Biointelect provides a range of services for biopharmaceutical and medical device companies seeking to commercialise new technologies globally. We conduct detailed market evaluations and we define optimum clinical, regulatory, reimbursement and market-entry strategies.

For early stage companies we provide commercial and market insights to support product development. We can also assist with portfolio prioritisation and partnering.

For late stage companies, we have a proven track record in new product planning, start-up development and identifying the right commercial partners.

Commercialisation

Whether your product is pre-clinical, pre-market or in-market, we can help you evaluate and optimise value.

  • Market Evaluation
  • Market analysis
  • Forecasting
  • Market Research
  • KOL Engagement
  • Advisory boards
  • Competitive Pipeline Analysis
  • Pricing and Reimbursement Considerations
  • Channel to Market Analysis
  • “Reality Check”

Partnering

Biointelect provides a range of partnering services for our clients.

Pharmaceutical and Biotech companies either have or are looking for technologies (known as assets). Partnering is the process by which an asset is sold or licenced.

The partnering process can involve searching for partners with capabilities to commercialise the asset. Or looking (often known as scouting) for assets for companies that have existing capabilities to add to their portfolio.

We conduct detailed market evaluations and we define optimum clinical, regulatory, reimbursement and market-entry strategies.

1. Desk top research

  • Market research to identify potential candidate partners
  • Estimate market potential and build a business case
  • Screening of partner business model and portfolio to confirm strategic fit

2. Initial outreach

  • Contact potential partner to explore interest in opportunity
  • Follow up activities including exchange of non confidential information

3. Due diligence & negotiation

  • Set up virtual data room with all relevant information
  • Manage exchange of Confidential Information and support due diligence questions
  • Development of term sheet and draft documentation
  • Support negotiations through to final agreement

4. Close and handover

  • Execution of final transaction documents
  • Transfer of information to relevant project managers

Regulatory

We can help you develop your regulatory strategy and navigate the path to market with global regulatory authorities.

  • International regulatory strategy for pharmaceuticals, medical devices and IVDs
  • Regulatory submissions for pharmaceuticals and biologics
  • Regulatory submissions for devices and IVDs (PMA, 510 (k), IDE, CE and ARTG listings)
  • Essential Principles/Requirements and Technical Files (devices)
  • Pharmacovigilance (pre and post-market compliance, reporting and recalls)
  • Gap analyses

Clinical

Our team has extensive experience in the development and implementation of international clinical research strategies for drugs, biologics and devices.

  • International Clinical Research Strategies
  • Management of all phases of clinical trials for pharmaceuticals, devices and IVDs in compliance with ICHGCP and ISO14155
  • Investigational site assessment
  • Clinical study start up including protocol, IB, Informed Consent, CTN, ethics applications and contract negotiations
  • Operational procedures and training
  • Audit of investigational sites, sponsor, laboratory, and pharmacy

Quality

In order to comply with today’s complex regulatory environment we can build and refine a Quality Management System that meets your needs in compliance to ISO 13485, cGMP, ISO 9001 and GLP.

  • Policies and procedures, including QMS software implementation
  • QMS Compliance including Internal, supplier and partner audits (ISO 13485, cGMP, GDP, GWP)
  • Gap analyses, process mapping and re-engineering; risk assessments