. SPECCRO

Services We Offer

Drug Development & Regulatory Strategy

Drug Development Packages (End-to-End)

  • Biology & Efficacy.
  • ADME / PKPD & Translational Plan.
  • Target & Chemical Safety Assessment.
  • IND & FIH Strategy; ADME; Tox; Clin. Pharm.
  • Due Diligence & Derisking prior to funding.

Key Specialty Areas

  • In silico / computational, QSP, Bio-statistics, Omics & Emerging tools.
  • In-vitro / 2D / 3D ADME & Safety Pharm / Tox.
  • Traditional & Specialized In-vivo Models.
  • Mechanistic & Specialty Toxicology.
  • Tx Pharmacology, Pathology, Biomarkers.
  • Regulatory Writing & Submissions & interactions.

Therapeutic & Modality Focus

  • Oncology, Neurology, Ophthalmology, Cardio-Renal-Metabolic, Immunology/IO.
  • Traditional & Complex Modalities.
  • Rare & Common Diseases Indications.

Project Management Vendor Selection Monitoring & Auditing

Industry- Leading Leadership
(Active consultants, pharma executives & both)

  • Decades of practical drug development & technology leadership, with specialized NAMs expertise & extensive networks.

Curated CRO Network

  • Execute through CROs & technology network, accessing proven tools & NAMs.
  • Expand company’s research capabilities beyond the reach of larger organizations or startups.

Portfolio & Project Management

  • Cross functional integrator, scientific oversight, troubleshooting multiple areas.
  • Tangible financial benefits for sponsors due to previously negotiated prices.

Innovating to Derisk and Accelerate Drug Development

NAMs,
Derisking Tools &
Execution

01

Target/compound selection and Derisking

Design & implementation of in silico & screening tools to select compounds with optimized safety profile; Mechanistic tools to understand human relevance of safety findings.

02

Computational tools for safety screening & prediction (examples)

QSAR for DNA reactive impurity & AMES for mutagenicity DILI prediction: e.g., in silico FIH Modeling for dose prediction.

03

MPS examples to predict human biology

Weight of Evidence for carcinogenicity, reprotoxicity e.g., iPSC methodologies QT Prolongation Human iPSCs to screen for proarrhythmic effects DILI: Human Liver-Chip to predict hepatotoxic drugs.

04

Implementation of NAMs technologies

Holistic implementation of NAMs in Drug development based on complexity & stage of drug development.

05

Vendor selection and management through our curated network

Negotiate and select vendors around sponsor priorities, ensuring high quality while balancing cost and speed.

06

Fractional regulatory and strategic expertise

Scalable leadership solutions with no long‑term commitment; unrivaled regulatory, nonclinical, clinical, and biostatistics experience across therapeutic areas.

Services Scenarios

Startup Company

START UP COMPANY

  • We develop nonclinical plans with clear timelines and cost estimates across lean and traditional regulatory packages and to strengthen partnership and investor pitches.
  • We guide early regulatory engagement for in vitro only oncology programs, including those with unique routes of administration.
Biotech Company

BIOTECH COMPANY

  • We strengthen preclinical dossiers by applying cross molecule learnings and off target risk assessments without relying on animal studies.
  • We build streamlined preclinical IND packages grounded in established mechanisms of action and clinical experience.
  • We integrate NAMs to enhance regulatory packages in place of traditional in vivo studies.
Pharma Company

PHARMA COMPANY

  • We de-risk and advance assets into clinical development.
  • We provide strategic guidance and coordinate resources from compound selection through IND in neuroscience, leveraging NAMs.
  • We supply dedicated specialty expertise to resolve preclinical challenges without burdening internal FTEs.

Service Models (Examples)

Individual Expert Consultant Support

Providing ophthalmology expertise to support preclinical development strategy.

Engaging a board-certified reproductive or immunotoxicologist for study design, issue resolution, or regulatory responses.

Functional Outsourcing

Fully outsourcing a GLP single-species dog tox program to a pre-vetted CRO.

Engaging a specialized laboratory to de-risk/manage a potential development-limiting toxicology finding through targeted investigative studies.

Integrated Cross- Functional Teams

Deploying an asset team; discovery biologist, ADME/PK scientist, toxicologist, regulatory and clinical pharmacologist to rapidly scale resources and accelerate program progression for a biotech client.