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43 results for “GMP compliance”

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Modalities

AAV / Viral Vector PlatformAntibody-Drug Conjugate (ADC)Biologics (Monoclonal Antibodies)Biologics (Other)Cell TherapyGene TherapyMicrobiome TherapeuticOligonucleotidePeptideRadiopharmaceuticalSmall MoleculeSynthetic BiologyVaccinemRNA

Development capabilities

Analytical method developmentFormulation developmentICH stability testingSolid-state characterizationCell line development

Manufacturing capabilities

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Drug Substance (DS)Drug Product (DP)

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Exploratory / CMCClinical supplyCommercial

Select biologics or small-molecule modalities above to reveal modality-specific manufacturing filters.

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FDA (US)EMA (Europe)NMPA (China)PMDA (Japan)ANVISA (Brazil)

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Services

AAV Manufacturing
ADC (Antibody-Drug Conjugate) Manufacturing
ADC Payload & Linker Synthesis
API Synthesis & Manufacturing
Allogeneic Cell Therapy Manufacturing
Autologous Cell Therapy Manufacturing
Bioconjugation Services
Biologics Development & Manufacturing
CMC Analytical Development
CMC Regulatory Submission Support
Cartridge Filling
Cell Therapy Manufacturing
Cell-Line Development
Cold-Chain Storage & Logistics
Combination Product Assembly & Final Packaging
Controlled Substance Manufacturing
Downstream Processing
Extractables & Leachables Studies
Flow Chemistry & Continuous Manufacturing
Formulation Development
HPAPI Manufacturing (High-Potency)
Inhalation & Nasal Dosage Manufacturing
Lentiviral Vector Manufacturing
Lipid Nanoparticle (LNP) Formulation
Lyophilization (Freeze Drying)
Microbial Fermentation
Microbiome / Live Biotherapeutic Manufacturing
Monoclonal Antibody (mAb) Manufacturing
Oligonucleotide Manufacturing
Ophthalmic Manufacturing
Oral Solid Dosage Manufacturing
Peptide Manufacturing
Prefilled Syringe (PFS) Filling
Process Development
Quality Control Testing
Recombinant Protein Manufacturing
Secondary Packaging & Labeling
Serialization & Track-and-Trace
Small Molecule Development & Manufacturing
Solid-State Chemistry & Polymorph Screening
Stability Testing & Storage
Sterile Fill-Finish & Aseptic Manufacturing
Technology Transfer
Topical & Semi-Solid Manufacturing
Upstream Processing
Vaccine Manufacturing
Vial Filling
Viral Vector Manufacturing
mRNA Manufacturing

Reviews

Has reviewsMin overall rating

Review-based filters and average ratings stay secondary until the directory-wide review signal gate opens (see how reviews work). Result averages are hidden in listings until then.

Codis
- CMC Analytical Development
- CMC Regulatory Submission Support
- Formulation Development
Global CDMO specializing in commercial-scale spray drying, amorphous solid dispersions, microencapsulation, and continuous granulation with 400,000 sq ft of GMP manufacturing across US and UK facilities.
C
CRAMSN
- CMC Analytical Development
- API Synthesis & Manufacturing
- CMC Regulatory Submission Support

Filters

Modalities

Development capabilities

Analytical method developmentFormulation developmentICH stability testingSolid-state characterizationCell line development

Manufacturing capabilities

Manufacturing stream

Drug Substance (DS)Drug Product (DP)

Production scale

Exploratory / CMCClinical supplyCommercial

Select biologics or small-molecule modalities above to reveal modality-specific manufacturing filters.

Regulatory clearances

FDA (US)EMA (Europe)NMPA (China)PMDA (Japan)ANVISA (Brazil)

Geographic footprint

Regions

United States
Canada
Europe
Asia-Pacific
Latin America
Middle East
Africa

Countries

Afghanistan
Åland Islands
Albania
Algeria
Andorra
Angola
Anguilla
Antigua & Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bhutan
Bolivia
Bosnia & Herzegovina
Botswana
Brazil
British Indian Ocean Territory
British Virgin Islands
Brunei
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Caribbean Netherlands
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo - Brazzaville
Congo - Kinshasa
Costa Rica
Côte d’Ivoire
Croatia
Cuba
Curaçao
Cyprus
Czechia
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Eswatini
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Honduras
Hong Kong SAR China
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Kosovo
Kuwait
Kyrgyzstan
Laos
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macao SAR China
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar (Burma)
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
North Korea
North Macedonia
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestinian Territories
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn Islands
Poland
Portugal
Puerto Rico
Qatar
Réunion
Romania
Russia
Rwanda
Samoa
San Marino
São Tomé & Príncipe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Korea
South Sudan
Spain
Sri Lanka
St. Barthélemy
St. Kitts & Nevis
St. Lucia
St. Martin
St. Pierre & Miquelon
St. Vincent & Grenadines
Sudan
Suriname
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad & Tobago
Tunisia
Türkiye
Turkmenistan
Turks & Caicos Islands
Tuvalu
U.S. Virgin Islands
Uganda
Ukraine
United Arab Emirates
United Kingdom
United Kingdom
United States
Uruguay
Uzbekistan
Vanuatu
Vatican City
Venezuela
Vietnam
Wallis & Futuna
Western Sahara
Yemen
Zambia
Zimbabwe

Services

AAV Manufacturing
ADC (Antibody-Drug Conjugate) Manufacturing
ADC Payload & Linker Synthesis
API Synthesis & Manufacturing
Allogeneic Cell Therapy Manufacturing
Autologous Cell Therapy Manufacturing
Bioconjugation Services
Biologics Development & Manufacturing
CMC Analytical Development
CMC Regulatory Submission Support
Cartridge Filling
Cell Therapy Manufacturing
Cell-Line Development
Cold-Chain Storage & Logistics
Combination Product Assembly & Final Packaging
Controlled Substance Manufacturing
Downstream Processing
Extractables & Leachables Studies
Flow Chemistry & Continuous Manufacturing
Formulation Development
HPAPI Manufacturing (High-Potency)
Inhalation & Nasal Dosage Manufacturing
Lentiviral Vector Manufacturing
Lipid Nanoparticle (LNP) Formulation
Lyophilization (Freeze Drying)
Microbial Fermentation
Microbiome / Live Biotherapeutic Manufacturing
Monoclonal Antibody (mAb) Manufacturing
Oligonucleotide Manufacturing
Ophthalmic Manufacturing
Oral Solid Dosage Manufacturing
Peptide Manufacturing
Prefilled Syringe (PFS) Filling
Process Development
Quality Control Testing
Recombinant Protein Manufacturing
Secondary Packaging & Labeling
Serialization & Track-and-Trace
Small Molecule Development & Manufacturing
Solid-State Chemistry & Polymorph Screening
Stability Testing & Storage
Sterile Fill-Finish & Aseptic Manufacturing
Technology Transfer
Topical & Semi-Solid Manufacturing
Upstream Processing
Vaccine Manufacturing
Vial Filling
Viral Vector Manufacturing
mRNA Manufacturing

Reviews

Has reviewsMin overall rating

CRAMSN is a contract research, development, and manufacturing organization (CRO/CDMO/CMO) offering end-to-end solutions for drug substance and drug product development with GMP-certified facilities recognized by US, EU, Japan, and Canada regulatory authorities.

Cross-listed on cro.directory

Omniabio

Allogeneic Cell Therapy Manufacturing
CMC Analytical Development
Autologous Cell Therapy Manufacturing

OmniaBio is a cell and gene therapy CDMO specializing in process development, analytical development, and GMP manufacturing for lentiviral vectors, iPSCs, and immune cell-based therapies. The company operates a 120,000 sq ft facility in Hamilton, Ontario, integrating AI, automation, and robotics to deliver scalable manufacturing from preclinical to commercial stages.

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