From a single method that's failing validation to a full analytical lab being built from scratch — MolWard provides hands-on scientific consulting grounded in GMP practice and regulatory experience across ICH guidelines.
Each engagement is scoped and executed directly by a Ph.D. pharmaceutical scientist with hands-on experience at every stage of analytical and regulatory work.
Design, development, and ICH Q2-compliant validation of chromatographic and physicochemical methods for drug substances and drug products. Includes forced degradation studies, impurity profiling, and Validation Master Plan preparation.
Design and oversight of GMP stability programs for APIs and finished products, including accelerated, long-term, and photostability studies. Statistical shelf-life projection per ICH Q1E, OOS/OOT investigation, and CAPA implementation.
Gap assessment and remediation of analytical QA/QC systems, data integrity frameworks, and SOP infrastructure. Preparation and review of Validation Master Plans and analytical documentation packages for regulatory submissions.
Regulatory strategy for ICH Q-series guidelines covering analytical procedures, stability, impurities, and genotoxic impurity risk assessment. Practical guidance on bridging existing documentation to current ICH requirements.
Independent technical audits of pharmaceutical laboratories, CROs, and CDMOs. Assessment covers quality management systems, data integrity, analytical capabilities, and GMP compliance — with structured findings suitable for management or partner review.
Practical guidance for building or expanding a pharmaceutical analytical laboratory — from instrument selection and procurement strategy to installation, operational, and performance qualification (IQ/OQ/PQ) documentation.
Every engagement starts with a conversation, not a template. Work is executed directly — not delegated.
We talk through your situation — what's stuck, what's at stake, and what a useful outcome looks like. No commitment required.
A concise written scope covering deliverables, timeline, and pricing. Structured as fee-for-service or retainer depending on the engagement.
Work is carried out directly by Manuel Alves Falcao, Ph.D. You get the scientist, not a project manager relaying findings.
Documentation, protocols, reports, or recommendations in a format ready for your quality system or regulatory dossier.
Background, publications, and full work history available on LinkedIn →
Method development, stability setup, or analytical troubleshooting on drug programs where internal bandwidth is stretched.
Independent technical review, method transfer support, or QMS gap assessments prior to client audits or regulatory inspections.
Analytical and regulatory strategy for teams building their first GMP-compliant quality infrastructure without a full in-house team.
ICH Q-series guideline alignment, dossier preparation review, and analytical data package assessment before regulatory submission.
Technical evaluation of analytical programs, laboratory capabilities, and quality systems in acquisition or partnership assessment contexts.
Equipment selection, qualification protocols, and workflow design for new analytical labs or expansions moving toward GMP compliance.
Send a brief description of what you're working on. Engagements are scoped individually — no minimum commitment.