Statistical Outsourcing Services Competitors

Dow Development Laboratories (DDL) designs, develops, tests and manufactures topical drug products, including creams, gels, ointments, pastes, solutions, and suspensions. The company has specialized expertise in formulating small molecules, peptides, proteins, new chemical entities, combination products and generics. The project teams apply their topical product development experience and customer service focus on clients' programs, taking a concept through formulation development, screening, non-clinical studies and clinical supplies, toward successful regulatory approval. DDL has extensive expertise in the following areas: Formulation Development and Optimization, following QbD principles and always with the patient in mind Analytical Method Development and Validation R&D, GLP and GMP Clinical Supplies Manufacturing Clinical Labeling and Distribution ICH Stability (reach-in and walk-in chambers) In Vitro Release Testing (IVRT) CMC Program Strategy and Pharmaceutical Development Reports

Synergy Bioscience is a DEA-licensed and CLIA-certified CRO. As an FDA-registered facility, we take great pride in upholding the highest quality standards in the industry. We support pharmaceutical, biotech & medical device companies in expediting product commercialization, R&D, laboratory analysis & consulting services. Specializing in transforming complex pharmacological challenges into breakthroughs, we offer integrated analytical services for all stages of drug development. Our testing services include, but are not limited to: Analytical Chemistry Microbiology Testing Structural Chemistry Extractables and Leachables Elemental Impurities Cannabinoids Testing Formulation Studies Pharmaceutical Development Clinical Samples Testing Cleaning Validation FDA Audit Remediation Regulatory Filing Services Drug Metabolism Testing Regulatory Filing Services Cell & Gene Research Nanomedicine GC/MS, LC/MS, HPLC, therapeutic protein Analysis

Quality Systems Compliance LLC serves the needs of businesses working in the ISO and FDA GMP Regulated Industries including Medical Devices, Pharmaceuticals, Tissues, Quality Systems Compliance LLC can help you achieve and maintain quality compliance, while meeting deadlines and containing costs. If you plan and implement your quality system correctly, it doesn't have to be expensive to be in a state of compliance. In fact, implementing your quality system correctly the first time can reduce risk and liability. We can help your company plan, implement, and maintain a compliant quality system. Quality Systems Compliance LLC provides auditing support including GAP ASSESSMENTS, INTERNAL AUDITS, SUPPLIER AUDITS, and DUE DILIGENCE AUDITS. Quality Systems Compliance LLC offers training in quality systems, quality control, assurance, and quality compliance. Additionally, courses are available in statistics, process validation, Design of Experiments (DOE), Gage R&R and Measurement System Analysis (MSA). Quality Systems Compliance LLC can provide support before, during, and after ISO and FDA Inspections including 483 and Warning Letter responses.