ENABLE Pharm. Dev. Consulting
An End-to-End, full service CMC (Chemistry, Manufacturing, Controls) consulting firm to enable and empower small biotechs to reach their milestones at a rapid pace in a cost-effective manner.
A Full Service Experience
A Full Service Experience
Pharmaceutical Development CMC (Chemistry, Manufacturing, and Controls) consulting through all phases from discovery to commercialization
Preclinical formulation
Solution, suspension, SEDDS, nanosuspension, SDD, LNP to support discovery, PK and tox studiesPreclinical formulation
Drug Substance (API)
Modalities: small molecule, peptides, oligonucleotide, covalent molecule, monoclonal antibodies, ADC. Process R&D, route scouting, impurity control, process optimization, specifications, cGMP manufacturing and release. GLP and GMP batch production, DoE, QbD, PPQ, registration, validationDrug Substance (API)
Solid State/Preformulation
Polymorph, salt screening, physiochemical characterization such as solubility, permeability, pKa, Logp/LogD, and solid characterization such as density, flowability, compressibility, PSD, melting point, hygroscopicity, and solid/solution stabilitySolid State/Preformulation
Drug Product
Oral (tablet, capsule) and parenteral (solution and lyophilized powder, IM, IP). Pediatric, fixed dosing combination.Formulation design, process optimization, cGMP manufacturing and release, DoE, QbD, PPQ, registration, validationDrug Product
Analytical/Quality Control
Forced degradation, stability indicating method development/verification/validation, release, ICH stability studiesAnalytical/Quality Control
Clinical Packaging/Supply
HDPE bottle, blister, label, carton design. Depot and distribution. Clinical Packaging/Supply
Quality Assurance
Quality system, SOP, audit, batch record review, QP declaration, deviation, CAPA, OOS investigation. Quality Assurance
Supply Chain
Geographically diverse. Raw material sourcing, vendor qualification, logistics. Supply Chain
Intellectual Property
Patent extension, new IP, life cycle management. Intellectual Property
Regulatory Affairs
Regulatory documents (IND, IMPD, Investigation Protocol, Pharmacy manual, Investigator Brochure, Briefing document) authoring and review; gap analysis, regulatory agency presentation and interactionRegulatory Affairs
Project Management
Strategic planning, day to day operation management, risk assessment and mitigation, timeline and cost control, effective communication at all levelsProject Management
Due Diligence
Critical examination, gap analysis. Due Diligence