About PreClinIQ

PreClinIQ, pronounced ‘PreClinic,’ embodies our commitment to excellence in preclinical science and consultancy. With the IQ suffix signifying intelligence, innovation, and insight, our name reflects our mission to provide clients with intelligent solutions and strategic guidance throughout the preclinical phase of drug development. At PreClinIQ, we blend scientific expertise with forward-thinking approaches to deliver tailored solutions that drive success and advance the forefront of healthcare innovation. 

At PreclinIQ, we specialize in managing preclinical science and execution, allowing our clients to concentrate on the core operations of their companies

We partner with our clients to:

  • Develop and execute preclinical drug discovery and development plans, guiding projects from conceptualization to approval.
  • Expedite timelines through tailored preclinical and CMC (Chemistry, Manufacturing, and Controls) strategies.
  • Implement plans efficiently using our proprietary project management tools.
  • Coordinate outsourced activities with qualified Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs). This includes study design, request for proposals, contract negotiation, study implementation, monitoring, data review, and report preparation.
  • Prepare regulatory documents such as Investigational New Drug applications (IB/IND), Common Technical Document (CTD) summaries and tables, Clinical Trial Applications (CTA), New Drug Applications (NDA), Biologics License Applications (BLA), and Marketing Authorization Applications (MMA).
  • Cultivate relationships with regulatory agencies, representing your company in pre-IND meetings and other interactions.
  • Conduct Gap Analyses for drug discovery and development programs.
  • Establish or provide the necessary team to support drug development initiatives.
  • Manage R&D budgets and projections effectively.
  • Estimate drug consumption for program requirements and planned studies.
  • Assist client companies in attracting partners and investors by preparing them for investor meetings and partnership opportunities.

Who's our star client?

We support Startups, Biotechs, Individual investigators, and Pharmaceutical partners worldwide in greatly expediting the preclinical development of pharmaceuticals.

 

Still wondering, how we can help? Contact us now to schedule a consult. 

Both new and established biotech

Both new and established biotech

  • Support in fundraising efforts through grants or investor interactions.
  • Gap Analyses for preclinical and CMC programs.
  • Cost and timeline estimates for IND (Investigational New Drug) programs.
  • Identification of science-based decision points for project advancement.
  • Due diligence reviews for potential acquisitions.
  • Preparation of clients for due diligence processes in acquisition scenarios.
individuals, early discovery, or academic partners

individuals, early discovery, or academic partners

Technology transfer assistance, analysis on freedom to operate, guidance on IP portfolio and gap analysis from conception to market journey. 

Venture Companies and investors

Venture Companies and investors

  • Detailed Gap Analyses for preclinical and CMC programs.
  • Thorough analysis of preclinical programs, identifying potential issues.
  • Guidance on next steps and developmental requirements for reaching the next milestone effectively.
Stealth Programs and Early Stage

Stealth Programs and Early Stage

We also support stealth startups in conducting market and landscape assessments. We operate on their behalf while maintaining complete anonymity for their entity.

Incorporate patient voice in your programs

Patient-voice

Our patient centric approach, truly sets up apart. Our company specializes in enabling the integration of the patient voice into every stage of drug development, from concept to approval. We certify the implementation of patient-centric strategies throughout the process. With years of experience in the field of rare and orphan diseases, our team has played pivotal roles in numerous programs advancing from discovery to clinical stages.

Recognizing the indispensable role of patient organizations and other Key Opinion Leaders (KOLs), we have fostered invaluable partnerships to ensure that program objectives address unmet medical needs effectively. We prioritize collaboration and transparent communication in all our endeavors.

It is our mission to utilize our expertise and passion to drive the development of patient-focused therapies. We advocate for open channels of communication between the industry, patient communities, and other key stakeholders. Together, we strive towards a shared goal of enhancing the quality of life for patients and their families.

let's collaborate on turning your innovative ideas into impactful breakthroughs.

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