Biotech & Pharmaceutical
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. 

Our Product Development Services

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, Alacrita’s preclinical team is well-equipped to support you with strategic, technical and regulatory expertise.


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


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


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

Interim Chief Medical Officer

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

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 development
consultants 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.

Number of consultants by education, and number of modalities/disease areas covered:


  • 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

Contact Us

Reach out today for more information on our product development services.

Biotech & Pharmaceutical Product Development Case Studies

Due diligence on the developability & investability of a cancer vaccine

Challenge: A newly-formed US biotech company has acquired the intellectual property and assets of a legacy cancer vaccine company that had ceased trading several years ago following...

Antiviral gap analysis for partnering and/or progression to IND

Challenge: A prominent researcher at an academic research institution had developed a class of small molecule compounds with in vitro antiviral activity against a family of RNA viruses. The...

Regulatory strategy and preparation for pre-IND meeting with the FDA

Challenge: A biotech company working in the microbiome space engaged Alacrita to provide advice about regulatory strategy and to prepare for and conduct a pre-IND meeting with the FDA. The...

Validating two potential hormone replacement therapy products with KOLs

Challenge: A clinical-stage company developing novel transdermal patch technology asked us to validate two potential hormone replacement therapy products with KOLs. The main focus was to...

Oligo technology applications mapping

Challenge: A startup with a novel technology for enzymatic synthesis of dsDNA approached Alacrita to assess potential opportunities for the technology in the biopharma space. Hitherto the...

LNP technology and competitive landscape

Challenge: A privately held biotech company using AI/machine learning/Big Data to develop novel LNPs and LNP formulations for particular payloads instead of using a traditional “trial and...