Product Development

Our expert teams are ready to support you through every step of the pharmaceutical product development process, leveraging our scientific, clinical and commercial expertise to help you maximize value at each stage.

About our product development capabilities

From preclinical strategy to hands-on clinical development support, Alacrita provides a range of product development services covering the full product life cycle. Our consultants average 20-30 years of industry experience, allowing them to draw on significant first-hand knowledge to help clients progress optimally, while navigating today’s increasingly competitive, complex and rapidly-changing drug development environment. 

Our core team leverages our Expert Network, which contains over 150 expert product developmentconsultants who specialize in specific technologies and disease areas, across the below functional disciplines:

  • Biostatistics/Biometrics
  • Chief Medical Officer
  • Clinical Operations
  • Clinical Quality Assurance
  • Clinical Strategy/Oversight
  • CMC-Manufacturing
  • CMC-Regulatory/Quality
  • Discovery Biology
  • eCTD Regulatory Publishing
  • Intellectual Property
  • Medicinal Chemistry
  • Medical/Technical Writing
  • Pharm. Dev./Formulation
  • Preclinical Pharmacology
  • Project/Program Management
  • Regulatory Affairs
  • Supply Chain
  • Toxicology/Safety Pharm.

Research and IP evaluation

Our strategic guidance can help you extract maximum value from your IP portfolio, or if on the buy-side, support your asset acquisition with IP due diligence.

Preclinical Strategy & Execution

For any early-stage development needs, our preclinical team is well-equipped to support you with strategic, technical and regulatory expertise.

Clinical Development

Leverage the skills and experience of our seasoned drug development physicians to refine your clinical strategy and operations.

Regulatory Affairs

De-risk your regulatory interactions by tapping into our deep expertise in navigating US and EU agency regulations, submissions and responses.

CMC Consulting

Our pharmaceutical development, CMC-regulatory, QA and supply chain experts can help you chart the most efficient course through product development.

Interim Chief Medical Officer

Our frequently support its biotech clients with interim Chief Medical Officers.

Product modalities we can consult in:

  • Antibodies, ADCs
  • Biomarkers
  • Cell Therapy
  • Diagnostics
  • Discovery Platforms
  • DNA/RNA Drugs
  • Drug Delivery Tech.
  • Gene Therapy
  • Imaging Tools
  • Medical Devices
  • Medtech Software
  • Microbiome Drugs
  • Oncolytic Virus
  • Peptides/Protein Drugs
  • Radiopharmaceuticals
  • Small molecules
  • Vaccines

Disease areas we can consult in:

    • Autoimmune/Immunology
    • Cardiovascular
    • Central Nervous System
    • Congenital Disorders
    • Dermatology/Aesthetics
    • Digestive/GI
    • Ear
    • Endocrine and Metabolic
    • Fibrosis
    • Genitourinary Diseases
    • Haematology
    • Infectious Disease
    • Inflammation/Pain
    • Injuries and Trauma
    • Musculoskeletal
    • Non-medical
    • Oncology
    • Ophthalmology
    • Orphan Diseases
    • Respiratory
    • Urology (non-onc)
    • Women’s Health