505(b)(2)
83
Accelerated Stability Studies
149
ADMET
28
Aerosol Filling
15
Agglomeration
17
Analytical Laboratory Services
258
Analytical Methods Development
279
Analytical Validation Studies
200
Animal Health
74
Animal Model Services
28
Anti-Counterfeiting Technology
15
API Solubilization Technologies
42
Architectural Services
2
Aseptic Processing
103
Assay Development
163
Auditing
42
Automated Pharmacology
6
Bar Coding
29
Behavioral Monitoring
6
Bioanalytical Analysis LC/MS/MS
91
Bioanalytical Services
103
Bioavailability Studies
64
Biocatalysis
20
Biodiagnostic Manufacturing & Devices
12
Biodiagnostic Process Development
8
Biological Testing
80
Biologics Manufacturing
116
Biologics Process Development
91
Biomarker Research – Tissue Based
22
Biomarker Research & Validation
48
Biometrics
12
Bioprocess Validation
46
Bioprocessing
72
Bioprocessing, Disposable/Single-Use
55
Biosimilars
90
Biostatistics
33
Blending
64
Blood Sampling
10
Calibration
26
Cell Culture Media Development
37
Cell Line Construction & Development
62
Central Lab Services
30
cGMP Synthesis
87
Chemical Analysis
108
Chemical Cleaning
6
Chemicals and Raw Materials
91
Chemistry, Combinatorial
21
Chemistry, Computational
16
Chemistry, Medicinal
69
Chiral Separations, R&D
47
Chromatographic Analysis, LC/GC
126
Chromatography
95
CIP Process Systems
17
Clean in Place / Sterilization in Place (CIP/SIP)
31
Clean Room Equipment and Supplies
33
Clean Room Services
40
Cleaning Equipment
10
Clinical Analysis
36
Clinical Monitoring
36
Clinical Supply Management
59
Clinical Trials Management
87
Clinical Trials, Phase I
117
Clinical Trials, Phase II
115
Clinical Trials, Phase III
109
Clinical Trials, Phase IV
87
CMC (Chemistry, Manfacturing & Controls)
167
Coating & Lamination
26
Cold Chain Management
49
Commercial Drug Sourcing
28
Commissioning
12
Comparator Drug Blinding
22
Comparator Drug Purchasing
18
Construction Services/Management
9
Consulting
159
Consulting, Audits & Inspections
66
Consulting, Health, Safety & Environment (HS&E)
17
Consulting, Process Analytical Technology (PAT)
15
Consulting, Process Excellence
31
Consulting, Quality Management Systems
54
Consulting, Records Management
20
Consulting, Regulatory
104
Consulting, Six Sigma
8
Consulting, Talent
5
Container Testing
39
Contaminant Analysis
34
Contract Development and Manufacturing Organization (CDMO)
288
Contract Manufacturing
338
Contract Packaging
127
Contract Research
234
Contract Sales Organizations
12
Custom Fabricators
11
Custom Manufacturing
190
Custom Media Development
13
Custom Processors
14
Custom Protocols
33
Custom Sourcing
29
Custom Synthesis
98
Data Management
56
Database Systems
12
Disinfectants
12
Disposable Device Development & Manufacturing
21
Dissolution Testing
84
Distillation
21
Distribution, Clinical Trials
42
Distribution, Commercial
45
DMF Establishment / Maintenance
33
Documentation Support Services
44
Dosage Form Development
120
Downstream Processing
61
Drug Delivery Systems
118
Drug Design
42
Drug Development Services
186
Drug Discovery Support Services
88
Drug Screening
32
E-Commerce
11
E-Pedigree
3
Economic Development Organizations
1
Efficacy Testing
45
Electronic Data Capture
37
Electronic Data Management
40
Encapsulation
76
Endotoxin Testing & Removal
31
Engineering and Design Services
34
Enterprise Resource Planning
10
Environmental Analysis
27
Environmental Monitoring
36
European QP
24
Excipients
70
Expert Testimony
8
Extractables / Leachables Testing
64
Facility Construction
5
Facility Design
17
Facility Management Services
12
Facility Planning
17
Feasibility Studies
99
Fermentation
44
Filling, Ampule
48
Filling, Capsule
85
Filling, Cartridge
40
Filling, Syringe
82
Filling, Vial
140
Filtration Equipment & Supplies
21
Filtration Services
15
Filtration Testing and Certification
10
Flavors
8
Fluid Bed Processing
57
Forced Degradation Studies
78
Formulation Development
217
Formulation Services
160
Formulation, Controlled Release
83
Fragment-Based Screening
5
Gene Therapy & Testing Protocols
38
Genomics and Screening
14
GLP Auditing
20
GMP Auditing
50
Granulation
80
Hazardous Waste Analysis & Testing
5
Hazardous Waste Management
8
High Throughput Screening
31
Hot Melt Extrusion
31
HPLC
128
Imaging
30
Immunobiology Services
30
Immunotoxicity Testing
28
In Vitro Testing
95
In Vivo Testing
62
IND/NDA Submissions
70
Informatics
16
Investigator Recruitment
7
IT, 21CFR11 / Annex 11
21
IT, CAD/CAM
4
IT, Clinical Trials Management
20
IT, Data Collection
28
IT, LIMS
14
IT, Outsourcing Services
16
IT, Process Automation
28
IVR (Interactive Voice Response)
5
Laboratory Equipment and Supplies
55
Laboratory Glassware Washers
5
Lead Optimization
35
Library Synthesis
16
Lipids/Phospholipids
20
Litigation Support & Discovery
6
Logistics
39
Lot Release Testing
80
Lyophilization
92
Machinery Design and Construction
20
Mammalian Cell Culture
52
Manufacturing Equipment and Supplies
76
Manufacturing, Aerosol
10
Manufacturing, Antibody-Drug Conjugates
38
Manufacturing, API
135
Manufacturing, API, High Potency
62
Manufacturing, Aseptic Fill/Finish
123
Manufacturing, Bioequivalence
24
Manufacturing, Biologics
105
Manufacturing, Capsules
103
Manufacturing, Cartridges
18
Manufacturing, Clinical Trials Supply
141
Manufacturing, Consultants
37
Manufacturing, Controlled Substances
85
Manufacturing, Creams & Ointments
85
Manufacturing, Custom
136
Manufacturing, Cytotoxic & High Potency Compounds
70
Manufacturing, Dose Form, Non-Sterile
100
Manufacturing, Dose Form, Sterile
83
Manufacturing, Ethical
26
Manufacturing, Gels
71
Manufacturing, Generics
109
Manufacturing, High Containment Operations
54
Manufacturing, Inhalables
33
Manufacturing, Injectables
109
Manufacturing, Laboratory Equipment
46
Manufacturing, Liquids
122
Manufacturing, Lyophilized Products
70
Manufacturing, Microbial-based Therapeutic Proteins
28
Manufacturing, Nasal Delivery
43
Manufacturing, Nutraceuticals
60
Manufacturing, Oligonucleotides
33
Manufacturing, Ophthalmics
53
Manufacturing, Oral Drug Delivery
113
Manufacturing, Orally Dispersible Tablet
47
Manufacturing, OTC
88
Manufacturing, Other
73
Manufacturing, Parenterals, Large Volume
47
Manufacturing, Parenterals, Small Volume
78
Manufacturing, Peptides
67
Manufacturing, Powders, Non-Sterile
61
Manufacturing, Powders, Sterile
35
Manufacturing, Proteins
68
Manufacturing, Semisolids
59
Manufacturing, Soft Gels
34
Manufacturing, Solid Dosage
114
Manufacturing, Solutions & Suspensions
98
Manufacturing, Suppositories
19
Manufacturing, Sustained Release
64
Manufacturing, Syringes, Pre-filled
67
Manufacturing, Tablets
103
Manufacturing, Topicals
68
Manufacturing, Vaccines
75
Manufacturing, Veterinary
46
Mass Spectrometry
90
Materials Analysis
50
Measuring & Testing Technology
22
Medical/Clinical Studies
30
Medicinal Chemistry
38
Metabolic Analysis
18
Methods Development
173
Methods Validation
163
Micro FT-IR Analysis
35
Microbial Fermentation
28
Microbiological Control Services
12
Microbiological Testing
79
Microdosing
12
Microencapsulation
30
Micronization
36
Microscopic Analysis
30
Mixing & Blending
67
Mixing and Granulating Equipment
31
Mycoplasma Testing
17
Nonclinical Research
55
Nutritional Support Analysis
9
Organic Synthesis
45
Packaging Equipment
40
Packaging, Anti-Counterfeiting
44
Packaging, Banding
17
Packaging, Blister
85
Packaging, Blister, Cold Form
46
Packaging, Capsules
79
Packaging, Certification
16
Packaging, Clinical Trial Materials
77
Packaging, Clinical Trials
75
Packaging, Closures
19
Packaging, Closures - Dispensing
8
Packaging, Compliance
41
Packaging, Consultants
41
Packaging, Creams & Ointments
62
Packaging, Design & Testing
53
Packaging, Development
67
Packaging, Electronic Pedigree
9
Packaging, Equipment, Custom
17
Packaging, Form/Fill/Seal
59
Packaging, Glass Bottles and Jars
36
Packaging, Glass Vials
52
Packaging, Injectables
71
Packaging, Labels
73
Packaging, Liquids
75
Packaging, Lotion Pumps
18
Packaging, OTC
78
Packaging, Parenterals
59
Packaging, Plastic Bottles and Jars
43
Packaging, Pouches
46
Packaging, Powders
53
Packaging, Private Labeling
12
Packaging, RFID Labeling
26
Packaging, Samples
51
Packaging, Services, Other
78
Packaging, Solid Dosage
84
Packaging, Spray Pumps
17
Packaging, Tubes
35
Packaging, Unit Dosage
58
Parenterals Development
53
Parenterals, Ampule Filling
22
Parenterals, Cartridge Filling
27
Parenterals, Dual Chamber Cartridges
4
Parenterals, Dual Chamber Syringes
5
Parenterals, Syringe Filling
52
Parenterals, Vial Filling
80
Particle Characterization
59
Particle Size Analysis
81
Particle Size Classification
44
Patient Recruitment
15
Pharmacodynamics
20
Pharmacogenomics
17
Pharmacokinetics
54
Pharmacology
31
Pharmacovigilance
26
Photostability
39
Physical Testing
56
Pilot-Scale Filling
57
Polymerase Chain Reaction
20
Preclinical Study Design
49
Preclinical Testing
96
Preclinical Testing Formulations
59
Preformulation
98
Process Analytical Technology (PAT)
37
Process Characterization
55
Process Development/Scale-Up Services
223
Process R&D
135
Process Validation Studies
119
Project Management
117
Protein Extraction/Purification
43
Protein Synthesis
18
Protein Synthesis, Solid State
8
Purification
57
QA/QC
181
Quality Control Testing
129
R&D Services
207
Radiopharmaceuticals
13
Raw Materials Analysis
80
Recruiting/Hiring
11
Regulatory Affairs Consultants
71
RFID Tracking
13
RNAi Technology
15
Safety
6
Scale-Up
154
Screening, Classifying
14
Serialization
72
Shipping
37
Site Selection
22
Size Reduction
25
Software
47
Spray Drying
45
Stability Studies
164
Stability, ICH
142
Statistical Analysis
33
Stem Cells
16
Sterile Filling
86
Sterility Testing
68
Sterilization
49
Storage
63
Supplier, Equipment
66
Supplier, Excipients
24
Supplier, Fine Chemicals
30
Supplier, Glass
6
Supplier, Primary Packaging Materials
18
Supplier, Raw Materials
37
Supplier, Secondary Packaging Materials
18
Supply Chain Auditing
16
Supply Chain Management
62
Sustained Release Delivery Systems
42
Syringe Filling
59
System Integration
20
Tablet Coating
80
Tablet Compression Tooling
9
Tablet Press Control Systems
8
Tablet Press Refurbishing
5
Tablet Press Replacement Parts
4
Tablet Presses
24
Tablet Punches and Dies
8
Tank Cleaning
1
Tank Equipment
8
Target Profiling
8
Technology Transfer
122
Thermogravimetric Analysis
12
Thermoplastic Extrusion
4
Thermoplastic Molding
4
Third Party Logistics (3PL)
20
Torque Testing
15
Toxicology Services & Analysis
48
Trace Metal Analysis, ICP
30
Training
54
Training: cGMP/HPB/FDA Compliance
28
Training: Process Validation
26
Training: Safety
14
Transdermals/Transmucosals
23
Translation Services
15
Trays, Soft Gel Drying
5
Trays, Vial Filling
21
UV-VIS Spectrophotometer Analysis
77
Validation, Clinical
38
Validation, Equipment Cleaning
38
Validation, Filtration
27
Validation, Manufacturing
98
Validation, Services
119
Virology
16
Vitamin Analysis
18
Warehousing
51
Water Testing: Chemical
28
Water Testing: Microbiology
40
Water Treatment Consulting
3
Wet Chemical Analysis
41
Wipes
7
Wipes Manufacturing
5
X-Ray Crystallography
16
X-Ray Fluorescence
9
X-Ray Powder Diffraction
21
X-Ray Spectroscopy
16
