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

Interim medical director for MAA submission

Challenge: On behalf of a European pharmaceutical company, one of Alacrita’s professionals acted as medical director for the registration of a new agent in a neuroendocrine indication in...

Developing vaccine products

Challenge The UK HIV Vaccines Consortium needed expert advice. The consortium was supporting and coordinating the development of several new HIV vaccines in academia. They needed guidance...

Applying to Early Access to Medicines (EAMS) at the MHRA

Challenge: Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation study. Direct...

EU value proposition and market access plan for orphan disease drug

Challenge: A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME...

US market access plan for antibody launch

Challenge: A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME...

Gap analysis & pre-IND meeting preparation for preclinical compound

Challenge: Our client planning to develop and commercialize a preclinical compound for metabolic disorders. The product had a wide therapeutic potential for disorders associated with...