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Pharma Services Category of Prague Scientific

Prague Scientific
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Prague Scientific

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2023, Corporate Presentation, GMP Certificate 2022, API Development Services

Product List 2023
Corporate Presentation
GMP Certificate 2022
API Development Services

VIDEO(s)

Prague Plant

Prague Plant

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 19 NEWS #PharmaBuzz

INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
19 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

19 All APIs, 19 Listed APIs

19 All APIs
19 Listed APIs

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

SERVICES

Analytical, Clinical Trials, API Manufacturing, Drug Product Manufacturing, API & Drug Product Development

Analytical
- 1 Analytical Testing Services
- 1 Analytical Method Development
Clinical Trials
API Manufacturing
- 1 GMP Manufacturing
Drug Product Manufacturing
API & Drug Product Development

INSPECTIONS & REGISTRATIONS

1 FDA, 30 EDQM

1 FDA
30 EDQM

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Prague Scientific

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34 All

01 8API Development

02 1Analytical Method Development

03 1Analytical Testing Services

04 1Capsule

05 1Clinical Development / Phase IIb-IV

06 1Compliance, Regulatory & Consulting

07 1Cream / Lotion / Ointment

08 6Formulation Development

09 1GMP Manufacturing

10 1Injectable / Parenteral

11 1Liquid

12 1Medical Writing & Language Translation

13 1Post Marketing

14 4Preformulation & Material Science

15 1Solution

16 1Spray

17 1Suspension

18 2Tablet

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34 All

01 34Prague Scientific

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34 All

01 34Czech Republic

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01

ROUTE SCOUTING SERVICES

ROUTE SCOUTING SERVICES

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ROUTE SCOUTING SERVICES

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific performs a literature search to establish current state-of-the art routes and to identify synthetic route options, including novel routes. It provides optimization on a small scale to select the most promising synthetic route.

Category : API Development

Sub Category : Route Scouting

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

02

SOLID FORM DEVELOPMENT

SOLID FORM DEVELOPMENT

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SOLID FORM DEVELOPMENT

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific provides screening and process development services for crystalline forms (polymorphs, hydrates, solvates, salts, cocrystals) and amorphous forms (amorphous APIs, co-amorphs and solid solutions by precipitation & hot melt extrusion).

Category : Preformulation & Material Science

Sub Category : Solid State Characterization

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

03

API PROCESS DEVELOPMENT & OPTIMIZATI...

API PROCESS DEVELOPMENT & OPTIMIZATION

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API PROCESS DEVELOPMENT & OPTIMIZATI...

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers process development & GMP operations with optimization of chemical reaction parameters utilizing DoE & QbD principles, as well as process validation of development APIs for clinical trials & commercial supply.

Category : API Development

Sub Category : Process Development & Optimization

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

04

API SCALE-UP

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API SCALE-UP

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific manufactures commercial APIs in the Prague kilolab, Ankleshwar (India) Pilot plant. It has various equipment available such as reactors 25-2500L, autoclaves 20-630L, isolation & drying units, milling equipment, spray dryer, etc.

Category : API Development

Sub Category : Scale-Up Capabilities

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

05

PARTICLE SIZE MODIFICATION

PARTICLE SIZE MODIFICATION

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PARTICLE SIZE MODIFICATION

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers particle size modification, API solubility enhancement systems, screening and process development of crystalline and amorphous forms.

Category : Preformulation & Material Science

Sub Category : Particle Size Reduction & Micronization

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

06

ANALYTICAL DEVELOPMENT

ANALYTICAL DEVELOPMENT

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ANALYTICAL DEVELOPMENT

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Pharma Service : Analytical

Prague Scientific

Prague Scientific offers analytical method development, validation and transfer, specification setting, stability and stress testing, CMC and dossier preparation.

Category : Analytical Method Development

Sub Category : Method Development and Validation

Pharma Service : Analytical

Service
Web Link

Capabilities
#ServicesBio

07

OLIGONUCLEOTIDE SYNTHESIS

OLIGONUCLEOTIDE SYNTHESIS

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OLIGONUCLEOTIDE SYNTHESIS

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers synthesis, purification, characterisation and analysis of oligonucleotides.

Category : API Development

Sub Category : Protein / Peptide

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

08

GMP OPERATIONS FOR COMMERCIAL MANUFA...

GMP OPERATIONS FOR COMMERCIAL MANUFACTUR...

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GMP OPERATIONS FOR COMMERCIAL MANUFA...

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Pharma Service : API Manufacturing

Prague Scientific

Prague Scientific offers process development & GMP operations with optimization of chemical reaction parameters utilizing DoE & QbD principles, as well as process validation of development APIs for clinical trials & commercial supply.

Category : GMP Manufacturing

Sub Category : Overview

Pharma Service : API Manufacturing

Service
Web Link

Capabilities
#ServicesBio

09

PREFORMULATION AND COMPOSITION OPTIM...

PREFORMULATION AND COMPOSITION OPTIMIZAT...

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PREFORMULATION AND COMPOSITION OPTIM...

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers API and powder characterization & reference product characterization involving reverse engineering of solid dosage form products and investigation of key characteristics using scanning electron microscopy and hot-stage microscopy.

Category : Preformulation & Material Science

Sub Category : Overview

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

10

FORMULATION DEVELOPMENT OF TABLETS

FORMULATION DEVELOPMENT OF TABLETS

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FORMULATION DEVELOPMENT OF TABLETS

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers formulation development for solid oral tablets with immediate, modified & delayed release. It has various technologies, including direct compression, encapsulation, dry & wet granulation, Wurster coating, etc.

Category : Formulation Development

Sub Category : Tablet

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

11

FORMULATION DEVELOPMENT OF CAPSULES

FORMULATION DEVELOPMENT OF CAPSULES

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FORMULATION DEVELOPMENT OF CAPSULES

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers formulation development for various drug delivery dosage forms, such as solid oral capsules with immediate release, modified release, delayed release, multi-unit delivery systems (pellets), etc.

Category : Formulation Development

Sub Category : Capsule

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

12

ORAL SUSPENSION DEVELOPMENT

ORAL SUSPENSION DEVELOPMENT

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ORAL SUSPENSION DEVELOPMENT

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers formulation development for various drug delivery dosage forms, such as oral suspensions and solutions.

Category : Formulation Development

Sub Category : Suspension

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

13

INJECTABLE SOLUTION & SUSPENSION DEV...

INJECTABLE SOLUTION & SUSPENSION DEVELOP...

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INJECTABLE SOLUTION & SUSPENSION DEV...

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers formulation development for various drug delivery dosage forms, such as injection solutions, suspensions, etc. It provides an injectable ampoule or vial filling line under a nitrogen atmosphere.

Category : Formulation Development

Sub Category : Injectable / Parenteral

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

14

STERILE AND NON-STERILE OINTMENTS

STERILE AND NON-STERILE OINTMENTS

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STERILE AND NON-STERILE OINTMENTS

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers finished dosage form production, including solid dosage forms, sterile and non-sterile ointments, sterile injectables, hormone solid dosage forms, etc.

Category : Formulation Development

Sub Category : Cream / Gel / Lotion / Ointment

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

15

CONTRACT MANUFACTURING FOR CAPSULES

CONTRACT MANUFACTURING FOR CAPSULES

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CONTRACT MANUFACTURING FOR CAPSULES

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Pharma Service : Drug Product Manufacturing

Prague Scientific

Prague Scientific offers contract manufacturing of various oral solid dosage forms, such as hard gelatin capsules, with production capacities ranging from 70 kg to 1,000 kg.

Category : Capsule

Sub Category : Overview

Pharma Service : Drug Product Manufacturing

Service
Web Link

Capabilities
#ServicesBio

16

CONTRACT MANUFACTURING FOR ORAL LIQU...

CONTRACT MANUFACTURING FOR ORAL LIQUIDS

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CONTRACT MANUFACTURING FOR ORAL LIQU...

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Pharma Service : Drug Product Manufacturing

Prague Scientific

Prague Scientific offers contract manufacturing of oral liquid dosage forms as drops, with a production capacity of up to 1,500 kg.

Category : Liquid

Sub Category : Overview

Pharma Service : Drug Product Manufacturing

Service
Web Link

Capabilities
#ServicesBio

17

SUSPENSION CONTRACT MANUFACTURING

SUSPENSION CONTRACT MANUFACTURING

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SUSPENSION CONTRACT MANUFACTURING

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Pharma Service : Drug Product Manufacturing

Prague Scientific

Prague Scientific offers contract manufacturing of oral liquid dosage forms, such as suspensions, with a production capacity of up to 1,500 kg.

Category : Suspension

Sub Category : Overview

Pharma Service : Drug Product Manufacturing

Service
Web Link

Capabilities
#ServicesBio

18

NASAL & TOPICAL SPRAYS

NASAL & TOPICAL SPRAYS

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NASAL & TOPICAL SPRAYS

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Pharma Service : Drug Product Manufacturing

Prague Scientific

Prague Scientific offers contract manufacturing of liquid dosage forms, such as nasal and topical sprays and otic drops, with a production capacity of up to 500 kg.

Category : Spray

Sub Category : Overview

Pharma Service : Drug Product Manufacturing

Service
Web Link

Capabilities
#ServicesBio

19

CONTRACT MANUFACTURING FOR OPHTHALMI...

CONTRACT MANUFACTURING FOR OPHTHALMICS

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CONTRACT MANUFACTURING FOR OPHTHALMI...

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Pharma Service : Drug Product Manufacturing

Prague Scientific

Prague Scientific offers contract manufacturing of sterile ophthalmic drops with the production scale of 5, 10 & 15 ml.

Category : Solution

Sub Category : Ophthalmic

Pharma Service : Drug Product Manufacturing

Service
Web Link

Capabilities
#ServicesBio

20

HORMONE ORAL SOLID MANUFACTURING

HORMONE ORAL SOLID MANUFACTURING

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HORMONE ORAL SOLID MANUFACTURING

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Pharma Service : Drug Product Manufacturing

Prague Scientific

Prague Scientific offers contract manufacturing of solid dosage forms (hormones), including film-coated tablets and capsules.

Category : Tablet

Sub Category : Steroid / Hormone

Pharma Service : Drug Product Manufacturing

Service
Web Link

Capabilities
#ServicesBio

21

CONTRACT MANUFACTURING FOR INJECTABL...

CONTRACT MANUFACTURING FOR INJECTABLES

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CONTRACT MANUFACTURING FOR INJECTABL...

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Pharma Service : Drug Product Manufacturing

Prague Scientific

Prague Scientific offers contract manufacturing of parenteral liquid dosage forms, including ampoules and vials.

Category : Injectable / Parenteral

Sub Category : Overview

Pharma Service : Drug Product Manufacturing

Service
Web Link

Capabilities
#ServicesBio

22

CONTRACT MANUFACTURING FOR SEMI-SOLI...

CONTRACT MANUFACTURING FOR SEMI-SOLIDS

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CONTRACT MANUFACTURING FOR SEMI-SOLI...

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Pharma Service : Drug Product Manufacturing

Prague Scientific

Prague Scientific offers contract manufacturing of semi-solid dosage forms, including topical gels, creams and ointments (sterile and non-sterile).

Category : Cream / Lotion / Ointment

Sub Category : Overview

Pharma Service : Drug Product Manufacturing

Service
Web Link

Capabilities
#ServicesBio

23

TABLET CONTRACT MANUFACTURING

TABLET CONTRACT MANUFACTURING

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TABLET CONTRACT MANUFACTURING

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Pharma Service : Drug Product Manufacturing

Prague Scientific

Prague Scientific offers contract manufacturing of oral solid dosage forms, including tablets, film-coated tablets, tongue-soluble tablets, chewable tablets, etc.

Category : Tablet

Sub Category : Overview

Pharma Service : Drug Product Manufacturing

Service
Web Link

Capabilities
#ServicesBio

24

SOLID FORM CHARACTERIZATION

SOLID FORM CHARACTERIZATION

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SOLID FORM CHARACTERIZATION

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers solid-form characterization, including X-ray powder diffraction, infrared and Raman spectroscopy, differential scanning calorimetry, and solid-state nuclear magnetic resonance.

Category : Preformulation & Material Science

Sub Category : Solid State Characterization

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

25

ROUTE EVALUATION SERVICES

ROUTE EVALUATION SERVICES

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ROUTE EVALUATION SERVICES

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific identifies synthetic routes options including designing novel routes. It provides laboratory assessment and optimization on a small scale to select the most promising synthetic route including preparation of standards of impurities.

Category : API Development

Sub Category : Route Evaluation & Development

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

26

PROCESS SAFETY DATA MEASUREMENT

PROCESS SAFETY DATA MEASUREMENT

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PROCESS SAFETY DATA MEASUREMENT

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific performs optimization of chemical reaction parameters utilizing Design of Experiments (DoE) & Quality by Design (QbD) principles (e.g. Cost of goods manufactured, yield, cycle time, quality etc.) with process safety data measurement.

Category : API Development

Sub Category : Process Safety Assessment

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

27

API FOR CLINICAL SUPPLY

API FOR CLINICAL SUPPLY

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API FOR CLINICAL SUPPLY

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers development of active pharmaceutical ingredients (APIs) for clinical trials and commercial supply.

Category : API Development

Sub Category : Clinical Supply

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

28

NITROSAMINE IMPURITY TESTING

NITROSAMINE IMPURITY TESTING

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NITROSAMINE IMPURITY TESTING

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Pharma Service : Analytical

Prague Scientific

Prague Scientific offers evaluation and method development for various nitrosamines impurities, genotoxic impurities in API, drug product and excipients.

Category : Analytical Testing Services

Sub Category : Impurity Isolation and Identification

Pharma Service : Analytical

Service
Web Link

Capabilities
#ServicesBio

29

FULL SCALE PHARMACOVIGILANCE SERVICE...

FULL SCALE PHARMACOVIGILANCE SERVICES

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FULL SCALE PHARMACOVIGILANCE SERVICE...

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Pharma Service : Clinical Trials

Prague Scientific

From early-stage development through the approval & launch of new products, Prague Scientific can assist with all regulatory needs across the entire product lifecycle. It offers full scale pharmacovigilance services with MA maintenance.

Category : Post Marketing

Sub Category : Pharmacovigilance / Product Lifecycle Management

Pharma Service : Clinical Trials

Service
Web Link

Capabilities
#ServicesBio

30

REGULATORY SUPPORT

REGULATORY SUPPORT

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REGULATORY SUPPORT

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Pharma Service : Clinical Trials

Prague Scientific

From early-stage development through the approval and launch of new products, Prague Scientific's regulatory experts can assist with all regulatory needs across the entire product lifecycle including regulatory submission and other regulatory services.

Category : Compliance, Regulatory & Consulting

Sub Category : Overview

Pharma Service : Clinical Trials

Service
Web Link

Capabilities
#ServicesBio

31

MEDICAL WRITING

MEDICAL WRITING

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MEDICAL WRITING

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Pharma Service : Clinical Trials

Prague Scientific

Prague Scientific offers medical writing services along with clinical and preclinical development plan, pilot and pivotal study design (PK, BES, PD, efficacy/safety), CRO qualification, etc.

Category : Medical Writing & Language Translation

Sub Category : Overview

Pharma Service : Clinical Trials

Service
Web Link

Capabilities
#ServicesBio

32

PK & PD ANALYSIS

PK & PD ANALYSIS

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PK & PD ANALYSIS

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Pharma Service : Clinical Trials

Prague Scientific

Prague Scientific conducts pilot & pivotal study design (PK, BES, PD, efficacy/safety), in vitro in vivo relationship, CRO qualification, selection by tender process and monitoring, study results evaluation & troubleshooting with medical writing services.

Category : Clinical Development / Phase IIb-IV

Sub Category : Pharmacokinetics / Pharmacodynamics / Pharmacometrics

Pharma Service : Clinical Trials

Service
Web Link

Capabilities
#ServicesBio

33

MODIFIED RELEASE FORMULATION DEVELOP...

MODIFIED RELEASE FORMULATION DEVELOPMENT

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MODIFIED RELEASE FORMULATION DEVELOP...

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers formulation development of oral solids such as immediate release, modified release, delayed release tablets and capsules with multi unit delivery systems (pellets).

Category : Formulation Development

Sub Category : Controlled / Immediate / Modified Release

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

34

NITROSAMINE IMPURITY SYNTHESIS & ANA...

NITROSAMINE IMPURITY SYNTHESIS & ANALYSI...

Luxepack

Not Confirmed

NITROSAMINE IMPURITY SYNTHESIS & ANA...

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Pharma Service : API & Drug Product Development

Prague Scientific

Prague Scientific offers synthesis and analytical characterization of nitrosamine standards with confirmatory nitrosamine testing on the ppb/ppm level (analytical method development and validation).

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

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