An in-depth look at key functional and therapeutic specialities

To help our clients evaluate if the Experts OnTap network is right for them, we have broken down many of our core functional and speciality areas.

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Product Development

Our drug development consultants allow your team to collaborate with seasoned drug development experts with comprehensive bio-pharmaceutical and biotechnology experience so that you can minimize risk, accelerate timelines and avoid pitfalls throughout the drug development continuum. Our consultants bring with diverse real-world functional and therapeutic experience in areas such as:

  • Formulations and Reformulations
  • Toxicology
  • Translation Science
  • Clinical Pharmacology and PK/PD
  • Modelling and Simulation
  • Non-Clinical and Clinical Strategy
  • Medical, Scientific and Regulatory Writing
  • Data Analysis and Management
  • Lead Optimization, Safety Assessment, Metabolism and Analytical Studies
  • DART and CARC timing/planning
  • CMC
  • Orphan Drugs
  • Cellular and Gene Therapies
  • Scientific Support

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Business Development / M&A

Our consultant’s work with our clients’ teams to supplement their existing capabilities bringing deep experience in both the buy and sell side, and the ability to bring targeted therapeutic expertise

  • M&A Due Diligence and Support
  • Licensing and Deal Making
  • Asset Scouting
  • Valuations

Product Development

Our consultants company formulate development strategies for pharmaceutical and medical products, ranging from lead candidate selection to final regulatory submissions and post-market activities. Our consultants have expertise in:

  • Comprehensive product development strategies meeting international standards, focusing on regulatory and toxicology requirements
  • Nonclinical studies required for next phase of Clinical Development
  • Management of Chemistry, Manufacturing and Controls (CMC) issues such as formulation changes, etc.
  • Timing and requirements for regulatory submissions to support ongoing development activities
  • Preparation, review, management and filing of submissions worldwide in Common Technical Document (CTD/eCTD) format
  • Pre-INDs, INDs, CTAs, BLA, NDAs, NDSs, MAAs, 510(k)s, PMAs, IMPDs, Pre-Submission Briefing documents, Investigator’s Brochures, Annual Reports, Integrated Summaries, etc.
  • Scientific writing of nonclinical data (safety), clinical data, and preparation of CMC documents
  • Manage nonclinical programs and Quality (CMC) components, and facilitate clinical programs to support registrations worldwide
  • Compliance activities, including development of compliance programs and conduct of facility audits for adherence to GLP and GMP standards

Clinical

Our clinical consultants come from all phases of drug, device and diagnostic development, providing diverse real-world experience and leveraging deep connections across the industry. Our consultants go deep in a variety of therapeutic areas. Whether you need someone who can help guide your team or step into the trenches, our consultants have clinical competencies which include:

  • Bio-statistics
  • Clinical Data Management
  • Clinical Operations (Patient Recruitment, Patient Retention & Site Engagement, Monitoring & Site Management, Project Management)
  • Clinical Regulatory Support (ANDA, 505(b)(2), BLA, IND, NDA, PMA) and Submission Support
  • Clinical Trials Planning and Design
  • CRO Selection, Contract Negotiation, and Management
  • Pre-Clinical and Clinical Research
  • Protocol Design and Development (Phase 1-4)
  • NDA/BLA/PMA Gap Analysis
  • Clinical gap analyses, product development plans, and due diligence assessments
  • Authoring of iPSPs, fast track/breakthrough therapy requests and orphan drug designation requests
  • Drug Safety and Pharmacovigilance

Commercialization

Our industry consultants bring a depth of knowledge in critical areas such as company and product strategies, pricing and reimbursement, market access, organizational structure and commercial operations build-outs, launch preparations, and supply chain management. Our consultants go deep in a variety of therapeutic areas. Whether you need someone who can help guide your team or step into the trenches, our consultants have clinical competencies which include:

  • Strategic Market Assessment (SMA)
  • Stakeholder/key opinion leader mapping
  • Forecasting
  • Sales force planning and design
  • Launch excellence
  • Project management/resource support
  • Market Access, Pricing and Reimbursement
  • Distribution Strategy and Execution

Marketing

Marketing pharmaceuticals, bio-pharmaceuticals, medical devices, and diagnostics, presents unique challenges and opportunities. Our consultants bring diverse real-world experience and leveraging deep connections across the industry. Our consultants are steeped in their therapeutic areas. Whether you need someone who can help guide your team or step into the trenches, our consultants have marketing competencies which include:

  • Brand Management
  • Competitive Intelligence
  • Digital Marketing
  • Downstream Marketing
  • HEOR (Health Economics and Outcomes Research)
  • KOL Strategy Development
  • Market Access/Payor Strategies
  • Marketing Communications
  • Product Launch
  • Pricing
  • Primary and Secondary Market Research
  • Product Portfolio Strategy and Management
  • Reimbursement
  • Social Media
  • Strategy
  • Upstream Marketing

Supply Chain

The complexity of pharmaceutical, medical device and diagnostic supply chains are growing exponentially. Our experts are steeped with real-world experience and deep therapeutic knowledge and can leverage deep connections across the industry. Whether you need someone who can help guide your team or step into the trenches, our consultants have supply chain competencies which include:

  • Supply Chain Strategy
  • Supply Chain Network Design and Optimization
  • Distribution/Logistics Network Design and Optimization
  • Supply Chain Support Systems
  • Site Optimization
  • Supply Chain Audits
  • Logistics Best Practices

Engineering

Whether you’re creating a new medical device, engineering the process for you new drug, or addressing a quality issue, working with experts that have tackled your exact problem can save time and money and bring the innovation you need. Our highly experienced consultants help you produce devices that make a difference.  Our consultant specialties include:

  • Facility and process planning and design
  • Automation and process controls
  • Process engineering
  • Facility and process validation
  • Occupational health and safety management
  • Environmental impact management Design concepting
  • Product Development
  • Prototyping
  • Clean Room Design and Building
  • Bioprocess Design
  • Process Efficiency
  • AAV Manufacturing Assessment
  • Injection, Liquid Silicone, and Micro Molding
  • Precision Machining
  • Validation
  • Manufacturing assessment and assembly
  • Bar-coding, packaging and labeling
  • Sterilization management

Manufacturing

Whether you’re doing a due diligence, assessing a new facility, considering an upgrade or addressing a quality issue, working with experts that have a depth in your manufacturing issues can save time and money and bring the innovation you need. Our highly experienced consultants bring a depth in areas such as:

  • Technology Transfer Strategy and Implementation
  • Formulation, Process, and Analytical Method Development and Validation
  • Product Process Improvement
  • QbD / PAT
  • Process Characterization and Control
  • Equipment Qualification
  • Facilities Start-Up, process planning and design
  • Clean Room Design and Building
  • Bioprocess Design
  • Process Efficiency
  • AAV Manufacturing
  • Manufacturing assessment and assembly
  • Quality-based manufacturing and analytical method development
  • Design, implementation and upgrade of manufacturing systems including small molecules, biologics and biosimilars
  • CMC and GCP

Regulatory Affairs

One of the most dynamically changing environments is regulatory. Regulatory authority requirements are constantly evolving, submission timeframes are shrinking, compliance demands are increasing, as the pressure mounts. Our consultants bring you the real-world experience with deep connections when require external resources to meet critical deadlines and manage peak demand. Our consultants are steeped in their therapeutic areas. Whether you need someone who can help guide your team or step into the trenches, our consultants (including a number who have worked at the FDA) have regulatory competencies which include:

  • Global and US Regulatory Strategy
  • Regulatory Strategy and Submissions for Biologics, Drugs, Devices, Diagnostics, Combination Products
  • Submission Authoring and Review for: New Drug Applications (NDAs) 505(b)(1) & 505(b)(2), Generic Drug Applications (ANDAs), Drug Master Files (all types) (DMFs) and the European Pharmacopoeia and Certificates of Suitability (CEPs), Marketing Authorization Application (MAA) Clinical Reviews, 510(k)s, BLAs, CTAs, HDEs, IDEs, INDs, SaMDs,
  • Audit Support
  • Experience with Meetings and Briefings for Biologics License Application (BLA) Meetings, Type 8 Meetings, Pre-Investigational New Drug (Pre-IND), End of Phase 2, Pre-New Drug Application (Pre-NDA), Advisory Committee, Orphan Designation (Formal Designation Request)
  • Regulatory CMC
  • Remediation Analysis and Support
  • Advertising and Promotional Review
  • Labeling for U.S. Submissions, Structured Product Labeling (SPL) Requirements and Analysis of Innovator Labeling, Side-by-Side Comparison
  • FMEA, FMECA, HA, ISO 14971 Analysis and Remediation

Sales Strategy

Our seasoned sales consultants help companies optimize their sales strategy and execution to drive profitable growth. Whether you are building a new team or turning around an existing team, our consultants bring the credibility of having done it before in with deep connections in their therapeutic area. Whether you need someone who can develop the strategy, step in to lead your team or get into the trenches, our consultants have sales competencies which include:

  • Commercialization Strategy
  • Sales Team Expansions
  • Sales Team Turnaround
  • Compensation Strategy
  • Distribution Networks – Local and Global
  • IDN and GPO Strategy and Execution
  • Training
  • Sales Organization Design and Restructuring
  • CRM Design and Implementation
  • Territory Evaluation and Design
  • Sales Team Evaluation and Effectiveness

Quality

Our experts will work with you to ensure your business continuously improves and reaches its goals through increased quality assurance. Steeped with real-world experience, whether you need someone who can help guide your team or step into the trenches, our consultants have quality competencies which include:

  • Quality Audits and Mock Inspections
  • CAPA and Root Cause Analysis
  • CFR Part 11
  • GMP, GCP, CVP, GVP, GSCVP, GLP, GCLP
  • Complaints, CAPA, AE process and systems
  • FDA Warning Letter Review, Response, and Mitigation
  • GCP
  • ISO13485
  • Labeling, Consistency and Accuracy
  • QMS Selection, Design and Implementation
  • SOP Development
  • Supplier Quality Audits
  • Outsourced Quality Support
  • Medical Device Single Audit Program (MDSAP)

Get in Touch to Learn More _

Do not hesitate to contact us with any questions or to learn more about Experts OnTap.