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.

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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 studies

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, validation

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 stability

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, validation

Analytical/Quality Control

Forced degradation, stability indicating method development/verification/validation, release, ICH stability studies

Clinical Packaging/Supply

HDPE bottle, blister, label, carton design. Depot and distribution.

Quality Assurance

Quality system, SOP, audit, batch record review, QP declaration, deviation, CAPA, OOS investigation.

Supply Chain

Geographically diverse. Raw material sourcing, vendor qualification, logistics.

Intellectual Property

Patent extension, new IP, life cycle management.

Regulatory Affairs

Regulatory documents (IND, IMPD, Investigation Protocol, Pharmacy manual, Investigator Brochure, Briefing document) authoring and review; gap analysis, regulatory agency presentation and interaction

Project Management

Strategic planning, day to day operation management, risk assessment and mitigation, timeline and cost control, effective communication at all levels

Due Diligence

Critical examination, gap analysis.

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