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Expert Advisory & Analytical Solutions

Bridging the gap between predictive cheminformatics and bench-level execution

MolWard is more than a state-of-the-art predictive software platform—it is backed by over 15 years of operational excellence in pharmaceutical R&D, Quality Control (QC), and Quality Assurance (QA).

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Whether you are a fast-moving biotech facing regulatory bottlenecks or an established pharma company looking to outsource complex method development, MolWard provides executive-level scientific consulting to de-risk your pipeline and accelerate your path to approval.

Our Core Consulting Services

1. Predictive Toxicology & ICH M7 Hazard Assessments

 

Do not have the internal bandwidth or specialized personnel to run in silico toxicology screens? Let us manage it for you.

 

  • You securely provide your target APIs, impurities, or SMILES strings. We run the comprehensive analysis using the MolWard dual-methodology QSAR and deterministic engine.

 

  • You receive regulatory-ready, highly detailed PDF reports complete with ICH M7(R2) compliance classifications, FDA CPCA nitrosamine potency scoring, and structural read-across justifications for your IND/ANDA submissions.

 

 

2. Analytical Method Development & Validation (ICH Q2)

 

Leverage our proven track record of securing regulatory approval for over 20 new generic products through rigorous method creation and validation.  

 

  • Hands-on expertise in developing, troubleshooting, and validating complex Stability-Indicating Methods (SIMs) and bioanalytical methods across diverse matrices. 

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  • Turnkey execution of method validations aligned with your Validation Master Plan (VMP), including complete protocol authorship, execution oversight, and final reporting. (Note: We have successfully led cross-functional teams through the completion of over 320 analytical method validations within a single year ).  

 

3. Stability Programs & Forced Degradation Strategy

 

Avoid catastrophic late-stage formulation failures with a proactive, data-driven stability strategy.

 

  • Comprehensive management of your stability testing programs, drawing on deep experience overseeing 1,500+ concurrent accelerated, long-term, and photostability studies.

 

  • Design and execution of empirical forced degradation studies to complement in silico predictions. We also provide expert resolution of Out of Specification (OOS) / Out of Trend (OOT) investigations and implement robust Corrective and Preventive Actions (CAPA).

 

4. Technical Auditing & Quality Systems Due Diligence

 

Ensure your external partners are operating to the highest global standards before you commit your capital.

 

  • Rigorous technical due diligence and auditing of external Contract Development and Manufacturing Organizations (CDMOs), CROs, and research units.

 

  • Comprehensive evaluations of partner Quality Management Systems (QMS), regulatory compliance, and analytical data integrity to support board-level accreditation, vendor selection, and funding decisions.  

Why Partner with MolWard?

When you hire MolWard for advisory services, you are not getting a junior analyst. You are partnering with a Ph.D. Pharmaceutical Scientist and Technical Lead who has directly managed multimillion-dollar drug portfolios across oral, semi-solid, and injectable dosage forms. We combine hands-on laboratory reality with advanced computational chemistry to solve your most complex regulatory headaches.

Ready to accelerate your pipeline?

Let’s discuss your current analytical bottlenecks.

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