R&D, TESTING AND REGULATORY SERVICES TO THE PHARMACEUTICAL AND PERSONAL CARE INDUSTRIES
ID - Contract Research Organization providing R&D, Testing, Regulatory and Consulting services to the pharmaceutical and personal care industries - Founded in 2008 by two researchers from the Pharmaceutical Technology Department of the Faculty of Pharmacy of University of Porto, Portugal CERTIFICATIONS: ISO 9001 Certified Approved by the French Ministry of Higher Education and Research (Crédit d'impôt Recherche) Approved by the Portuguese Ministries of Economy, Innovation and Development and of Science, Technology and Higher Education (SIFIDE) Spin-off of University of Porto MEMBER OF: PARTNERSHIPS: Clinica dentária do Amial Hospital de Gaia
OUR CLIENTS USA Canada Belgium Ireland France Spain Portugal UK Netherlands Germany Switzerland Italy Monaco Israel Japan Algeria Emirates South Korea Brazil South Africa
AREAS PERSONAL CARE PHARMACEUTICAL
PERSONAL CARE
FORMULATION - Formulation development Development of new facial, body or hair care formulas by classic or new formulation technologies, like micro or nanoparticle systems. - Formulation optimization Optimization of pre-existing formulas, through the improvement of stability, sensorial aspects (like colour, odour, texture and spreadability, etc.), safety and/or efficacy profile.
STABILITY Preliminary stability study (1 month) Accelerated stability study (3 months) Accelerated stability study (6 months) Stability test in real time conditions Compatibility product-packaging test PAO estimation PAO determination (lab test)
MICROBIOLOGICAL CONTROL Challenge test Total viable count Detection and Identification: Staphylococcus aureus Candida albicans Pseudomonas aeruginosa Escherichia coli Enterobacteriaceae Detection of specified and non-specified microorganisms API biochemical tests for bacterial identification Bactericidal test
EFFICCACY TESTS - SKIN CARE tests Hydration Desquamation/ Cohesion Anti-wrinkles Rejuvenating Firming Oily skin Pore size reduction Whitening Self-tanning Slimming and anti-cellulite Cleansing Barrier protection etc
EFFICCACY TESTS - HAIR CARE tests Hair strength or extensibility Keratin quantification by DSC Water quantification by DSC Hair combing Hair shine Hair color Hair density/ Hair loss / Hair thickness Hair growth Anti-sebum Anti-dandruff Anti-static charge test Anti-frizz
EFFICCACY TESTS - MAKE-UP tests: FACE Long-lasting Radiance / Illuminating Skin-tone matching Anti-wrinkles Firming Hydration Plumping Matifying Imperfections coverage Water-resistance Make-up remover - MAKE-UP tests: NAILS Easiness of application Time of drying Growth stimulation Long-lasting Water-resistance Detergents-resistance Colour coverage Shine Strength - MAKE-UP tests: EYELASHES Eyelash enhancement Volume adding Curling Lengthening Water-resistance Long-lasting - MAKE-UP tests: LIPS Moisturizing Smoothing Plumping Shine Long-lasting Water-resistance
EFFICCACY TESTS - ORAL CARE tests Dentin hypersensitivity Whitening efficacy (in vivo) Whitening efficacy (ex vivo) Anti-halitosis Anti-microbial (in vitro) Anti-microbial (in vivo) Anti-plaque Mouth ulcers
CONSUMER TESTS Evaluation of cosmetic products acceptability by consumers, after its use under pre-defined conditions. - Organoleptic characteristics (colour, odour, aspect, texture, spreadability, absorption rate, etc.); - Efficacy and intensity of perceived effects; - Tolerance; - Consumers' intention to buy the product.
SAFETY TESTS Acute cutaneous irritation test Cumulative cutaneous irritation test (patch test) Sensitization test (HRIPT) Ocular irritation Compatibility test (open test) under dermatologic control Tolerance test (use test) Tolerance test (use test) under dermatologic, ophthalmologic or gynecologic control Comedogenicity test under dermatologic control Stinging test Stinging test in damaged skin
REGULATORY Formula Review Safety Assessment Report Elaboration of both part A and part B of the Safety Assessment Report according with Annex I of the EU Regulation nr.1223/2009. Claim Substantiation Report Elaboration of a claim substantiation report according to Commission Regulation (EU) No 655/2013 of 10 July 2013, and respective guidelines PIF Elaboration of the product information file according with EU Regulation nr.1223/2009. Label Review Notification to EU Authorities (CPNP)
CONSULTING SERVICES Good Manufacturing Practices (GMP) Implementation according to ISO 22716 Including also: - training on the ISO standard requisites - Internal Audit - Accompaniment of the Certification audit.
SERVICES PHARMA FORMULATION QUALITY CONTROL IN VITRO ASSAYS CONSULTING AND MANAGEMENT
PHARMACEUTICAL Formulation - Development of classical formulations (liquids, semi-solids and solids); - Development of micro or nanoparticulate formulations (drug incorporation in microparticles, microcapsules, nanoparticles and nanocapsules); Formulation optimization, improving: stability; organoleptic characteristics (aspect, flavour and odour); drug delivery; drug absorption; etc.
PHARMACEUTICAL Quality control - Development and validation of analytical methodologies of HPLC for the assay of drug substances and related compounds; - Stability studies - Viscosity determination; - Dissolution testing; - Disintegration testing; - Apparent volume determination; - Angle of repose determination; - Granulometric determination; - Other
PROJECT MANAGEMENT Mod.003 Proposition Study Plan and Tecnhical Records Mod.034 Report
R&D, TESTING AND REGULATORY SERVICES TO THE PHARMACEUTICAL AND PERSONAL CARE INDUSTRIES