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Solutions for Each Stage of Development
From preclinical through to commercialization.
Our team’s integrated specialist skills enable to address current challenges, while
preparing for next steps along the product timeline.

Preclinical development enables drug candidates to progress from research to development, by linking discovery in the laboratory to testing in humans. Analytical methodology and manufacturing processes are established, and ramp up towards GMP compliance to support initial clinical trials. The product pharmacology, pharmacokinetic/biodistribution and toxicity profiles are explored, which ultimately aim to support the intended clinical trial design for first-in-human testing. Read More

VCLS Solutions

Define optimal clinical indication and labeling claims

  • Understand the product’s market, regulatory environment, and payer adoption drivers
  • Identify optimal therapeutic indication(s) and labeling claims
  • Outline a preliminary Target Product Profile (TPP), including commercial and clinical considerations
  • Identify the path to market
  • Outline a high-level development plan

Design and conduct preclinical programs

  • Identify and assess product-related risks
  • Define pre-clinical data necessary to enter the clinic
  • Identify predictive models and alternatives to animal testing
  • nonclinical product testing (including immunogenicity)

Develop analytical methodology and manufacturing processes

  • Identify product-related risks to be assessed and managed, key requirements for analytical methods and manufacturing processes development, regulatory requirements to adapt manufacturing and controls to subsequent stages of development
  • Select the most efficient predictive models and tools for linking manufacturing attributes with product specifications
  • Develop and qualify analytical methods (including potency assays)
  • Select, characterize and calibrate reference standard

Ensure quality compliance

  • Identify applicable GMP, and GLP requirements
  • Ensure compliance: initiate SOP writing, audit

Obtain early feedback from regulators

  • Seek regulators’ advice on nonclinical program, regulatory strategy, clinical development plan, manufacturing and testing approach
  • Input regulators’ opinions and recommendations into the development program, anticipate development obstacles, maximize chances to obtain approval for the product to move along the development timeline


































Preclinical development encompasses fundamental steps such as the definition of the device specifications, identification of the Mode of Action (MoA), foreseen intended use(s) and indication(s) for use, and the gathering of relevant data to support product safety for a first-in-human pilot study. A thorough risk analysis is performed to support the product global development plan. Read More

VCLS Solutions

Define optimal regulatory strategy, and target clinical indication

  • Understand the product’s market, regulatory environment, and market adoption drivers
  • Define the Mode of Action, Intended Use(s) and Indication(s) for use
  • Identify the regulatory path to the market: define applicable classification and regulatory requirements
  • Outline a high-level development plan, based on product risk analysis

Support analytical methods development and manufacturing compliance

  • Identify key requirements for analytical methods development and manufacturing processes, regulatory requirements to adapt manufacturing and controls to subsequent stages of development
  • Ensure compliance: SOP writing, and audit

Design and conduct nonclinical programs

  • Define nonclinical evaluation plan based on risk analysis
  • Identify appropriate partners for preclinical product testing

Obtain early feedback from regulators

  • Seek regulators’ advice on preclinical program,
  • Input regulator’s opinion and requirements into the global development program, anticipate development obstacles, maximize chances to obtain approval for the product to move along the development timeline