This website uses cookies in order to provide you with the best possible user experience. To agree to our use of cookies, continue browsing as normal. Visit our Cookies Policy to learn more about the cookies we use and for information about how to change your preferences.
This website uses cookies in order to provide you with the best possible user experience. To agree to our use of cookies, continue browsing as normal. Visit our Cookies Policy to learn more about the cookies we use and for information about how to change your preferences.

MULTIPLE SERVICES, ONE RELATIONSHIP

Preclinical to clinical phase drug development and lifecycle management, accessible through a single point of contact

DRUG DEVELOPMENT AND MANUFACTURING

Chemical Entity
PRECLINICAL
CLINICAL PHASES I & II
PHASE III, COMMERCIAL & LIFE CYCLE MANAGEMENT
Drug Substance
PRECLINICAL
CLINICAL PHASES I & II
PHASE III, COMMERCIAL & LIFE CYCLE MANAGEMENT
  • Analytical method development
    • Microbiology
    • Forced degradation studies
    • Assay-purity (HPLC/UPLC/LC-MS)
    • Water content
    • Elemental impurities (ICHQ3D)
    • Particle size distribution
    • Characterization (DSC, XRD, SEM, Raman, FTIR, microscopy)
    • Microbiology
    • Reference Substance Qualification
  • Stability studies
    • Forced degradation studies
    • ICH stability studies
    • ASAP (Accelerated Stability Assessment Program)
    • Structural analysis of unknown degradation products
  • Analytical method development
    • Analytical QbD
    • Robustness studies
  • Analytical method qualification and validation
    • Forced degradation studies
    • Assay/purity (Chromatographic and volumetric methods)
    • Validation protocols adapted to development stage
  • Quality Control
    • Characterization (DSC, XRD, SEM, Raman, FTIR, microscopy)
    • Full Pharmacopeial monograph (EP, USP, JP) or customer methods
    • Microbiology
    • Reference Substance Qualification
  • Stability studies
    • Excipient compatibility
    • Accelerated stability studies
    • ICH stability studies
    • ASAP (Accelerated Stability Assessment Program)
    • Structural analysis of unknown degradation products
  • Analytical method validation
    • Forced degradation studies (internal protocols and ANVISA requirements)
    • Verification and implementation of Pharmacopeial monograph (EP, USP, JP) or transfer of customer methods
    • Validation protocols in line with ICH, VICH, FDA guidelines
    • Analytical method transfer or co-validation with our customers or their CMOs
    • Method and Product Life Cycle Management
    • Statistical interpretation (ready for USP <1210> and Total Error Approaches)
    • Characterization (DSC, XRD, SEM, Raman, FTIR, microscopy)
    • Full Pharmacopeial monograph (EP, USP, JP) or customer methods
    • Microbiology testing and Antibiotic titration
    • Reference Substance Qualification
  • Analytical method update
    • Analytical QbD and QC friendly methods
  • Quality Control
  • Stability studies
    • ICH stability studies
    • ASAP (Accelerated Stability Assessment Program) for packaging studies
    • Structural analysis of unknown degradation products
Drug Product
PRECLINICAL
CLINICAL PHASES I & II
PHASE III, COMMERCIAL & LIFE CYCLE MANAGEMENT
  • Preformulation and formulation screening
  • Formulation development and manufacturing
    • Technologies poorly soluble drug candidates: nanosuspensions, solid dispersion, S(M)EDDS
    • Liquids, solids, semi-solids
    • Oral, parenteral, nasal, ophthalmic, buccal, topical
    • Techniques: direct compression, capsule filling, spray drying, wet granulation (high-shear, fluid-bed), dry granulation, wet nanomilling, lyophilisation
    • Controlled release systems: matrix tablets, coated beads
  • Analytical method development
    • Forced degradation studies
    • Dissolution
    • Content uniformity/homogeneity
    • Water content
    • Particle size distribution
    • Characterization (DSC, XRD, SEM, Raman, FTIR, microscopy)
    • Assay-purity (HPLC/UPLC/LC-MS)
    • Microbiology
  • Stability studies
    • Excipient compatibility
    • Accelerated stability studies
    • ICH stability studies
    • ASAP (Accelerated Stability Assessment Program)
  • GLP analysis of non clinical formulations
    • Method validation
    • Assay/purity and content homogeneity
    • Stability studies over the tox study duration
  • Commercial manufacturing (Small commercial batches and Orphan drugs)
    • Liquids, solids, semi-solids
    • Oral, parenteral, ophthalmic, topical
    • Techniques: direct compression, capsule filling, high-shear granulation, lyophilisation
    • Controlled release systems: matrix tablets
  • Process validation
  • Quality Control
    • Microbiology
  • Analytical method update
  • Analytical method validation
    • Assay/purity and preservatives (HPLC/UPLC/LC-MS)
    • Validation protocols in line with ICH, VICH, FDA guidelines
    • Statistical interpretation of method performance (ready for USP <1210> and Total Error Approaches)
    • Analytical Risk Management and Control strategy
    • Transfer design adapted to method performances
    • Analytical support to Process validation and Process Robustness studies
    • Reference Substance Qualification
    • EU retesting (Physico-chemical and Microbiological testing)
    • Dissolution (Type I, II and III) and In vitro Bioequivalence studies
    • Extractable and Leachable studies
    • Microbiological testing (Microbial contamination, Sterility, Preservative Efficacy Test, Endotoxins) and titration of antibiotics
  • Stability studies
    • ICH stability studies
    • ASAP (Accelerated Stability Assessment Program) for packaging selection
    • In-Use stability studies
    • Freeze/thaw, temperature cycling studies & transportation simulation
    • Leachable analysis
    • Stability study design optimization (Bracketing and Matrixing)
    • Structural analysis of unknown degradation products
  • Life Cycle Management of mature products and Analytical Methods
    • Analytical QbD approaches for method update for QC friendly methods
    • Reformulation of existing products and Market extension
Other Services
PRECLINICAL
CLINICAL PHASES I & II
PHASE III, COMMERCIAL & LIFE CYCLE MANAGEMENT
  • Pharmacology (Proof of concept)
    • Proof of concept: efficacy studies with already established models or models developed on purpose, In-Life and assay of biomarkers
  • Pharmacokinetics
    • Drug substance or formulation screening (Bioavailability, comparative PK…)
    • ADME studies (distribution, mass balance excretion, metabolism)
    • Descriptive PK
  • Bioanalysis for toxicology studies
    • Development or transfer of bioanalytical methods
    • Validation of bioanalytical methods
    • Transfer or validation
    • Assay of specimens
    • PK / TK interpretation
Biological Entity
PRECLINICAL
CLINICAL PHASES I & II
PHASE III & COMMERCIAL
Drug Substance
PRECLINICAL
CLINICAL PHASES I & II
PHASE III & COMMERCIAL
  • Microbial strains and cell lines
    • Microbial strains (aerobic/anaerobic, attenuated, spore formers)
    • Generation of microbial recombinant strains (E.coli, yeast, Bacillus, Streptomyces, …)
    • Generation of higher eukaryotic recombinant cells (insect, mammalian, human)
    • Production of Research Cell Banks
  • Upstream and downstream process development
    • Upstream process development
    • Downstream process development
    • Viral removal studies and validation
  • Analytical method development
    • Protein identity and purity (SDS-PAGE, Western Blot, ELISA, SEC-HPLC, LC-MS)
    • Protein quantification (UV, ELISA, Lowry, Bradford, µBCA)
    • Quantification of DNA
    • Quantification and characterization of Host Cell Proteins
    • Quantifications of process aids (such as anti-foam, protein A, Nickle, process enzymes, protease inhibitors)
    • Endotoxines
    • Bioactivity/Potency (enzymatic, cell based assays, ELISA)
    • Particle size distribution
    • Elemental impurities
    • Protein and DNA sequencing
    • Characterization assays
    • Microbiology (sterility, bioburden, cfu determination, identification, absence of certain microorganisms)
    • Qualification of analytical methods
  • Manufacturing
    • Production of research batches (from mg to larger quantities)
    • QC testing
    • Upscaling up to 400 liters
  • Stability studies
    • Development of stability indicating methods
    • ICH Real-time stability
    • Stress stability studies
Drug Product
PRECLINICAL
CLINICAL PHASES I & II
PHASE III & COMMERCIAL
  • Preformulation and formulation screening
  • Formulation development and manufacturing
    • Technologies: stabilization of biopharmaceuticals via spray drying and lyophilisation
    • Liquids, solids
    • Oral, parenteral, nasal, ophthalmic
    • Techniques: direct compression, capsule filling, spray drying, wet granulation (high-shear, fluid-bed), lyophilisation
    • Controlled release systems: colon targeting via coated capsules/mini-tablets
  • Analytical method development
    • Quantification of API
    • Quantifications of excipients
    • Endotoxines
    • Bioactivity/Potency (enzymatic, cell based assays, ELISA)
    • Particle size distribution
    • Elemental impurities
    • Characterization assays
    • Microbiology (sterility, bioburden, cfu determination, identification, absence of certain microorganisms)
    • Qualification of analytical methods
  • Stability studies
    • Development of stability indicating methods
    • ICH Real-time stability
    • Stress stability studies
Other Services
PRECLINICAL
CLINICAL PHASES I & II
PHASE III & COMMERCIAL

CONTACT US

Your message has been sent.

I’m
your name
from
your company,
your region
. I would like to discuss
select a topic
so please call me at
your phone number
or send an e-mail to
your e-mail address
and
leave your message.