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Understand the client's businesses needs in the perspective of people, process and technologies
Comptek pros INC
Foremost, our focus has been on people, who are the real pioneers of change, and decisive on making a business profitable or cause irreparable losses. We understand that, quality people running an organization is the first sign of success. To this end, we have fine-tuned, and updated our portfolio of services.
Our endeavors to establish new and innovative benchmarks in pharmaceutical and healthcare domain made us to offer following services. Most importantly, we can modify and adapt established standard practices to your specific requirements.
Comptek Pros Inc offers an interactive approach to global safety and pharmacovigilance. Our global Safety and Pharmacovigilance team has broad experience with a variety of databases and technology, in addition to concentrated experience with critically ill patients participating in global studies and numerous years of industry experience. Our Safety and Pharmacovigilance team excels at developing and maintaining interactive and multi-disciplinary relationships within the study team, with the goal of efficiently processing safety data by keeping key people involved and coordinating communications to sites to limit redundancy. This leads to rapid identification of any potential safety issues and resolution of any open events. The diligence and attention our sponsors receive from our Safety and Pharmacovigilance team is unique in the industry.
Comptek Pros Inc Regulatory Affairs Professionals are dedicated to ensuring the successful and timely submission of your application. We work closely with you to provide strategic regulatory guidance toexpedite the compilation and submission of your application Produce a submission acceptable to local global regulatory authorities. Our Services include:
1. Regulatory Consulting
2. Regulatory Operations
3. Electronic Submissions/eCTD
4. Medical Device Classification and Strategy
5. Report preparation/publishing/submission
6. Regulatory Intelligence Center
7. Post-submission support (e.g., annual reports, amendments, variations)
1. Regulatory Consulting
2. Regulatory Operations
3. Electronic Submissions/eCTD
4. Medical Device Classification and Strategy
5. Report preparation/publishing/submission
6. Regulatory Intelligence Center
7. Post-submission support (e.g., annual reports, amendments, variations)
Regulatory agencies across the world are moving to make electronic publishing following the Common Technical Document (CTD) format the preferred standard for submitting biologic and drug applications. Beyond this evolving regulatory requirement, the eCTD (electronic Common Technical Document) format also provides sponsors with the several benefits that:
Comptek Pros Inc E-publishing team understand that it takes more than document formatting, bookmarks and links to create an approvable FDA electronic submission. It requires content expertise — professionals who understand process, facility, and assay validation; who understand FDA expectations for preclinical and clinical data presentation and discussion; and who are familiar with the reviewer expectations in the various FDA review divisions.
Comptek Pros Inc E-publishing team understand that it takes more than document formatting, bookmarks and links to create an approvable FDA electronic submission. It requires content expertise — professionals who understand process, facility, and assay validation; who understand FDA expectations for preclinical and clinical data presentation and discussion; and who are familiar with the reviewer expectations in the various FDA review divisions.
Our experts provide accurate, regulatory-compliant clinical data solutions to our client needs. To ensure the integrity and accuracy of the study data, our Data Management Staff follow corporate QC and QA processes. Our QA process formally assesses compliance with corporate and study-specific SOPs.
2. Case Report Form (CRF) Design
3. Database design and Data Validation plan
4. Quality control testing of database
5. Data entry (double)
6. Data clarification, consistency/logic checks and querying
7. Medical Coding – MedDRA, WHO – ART, COSTART, WHODRUG
8. Data Validation and Query Management
Our data management services and procedures include
1. Data Management Plan (Quality Control Guidelines)2. Case Report Form (CRF) Design
3. Database design and Data Validation plan
4. Quality control testing of database
5. Data entry (double)
6. Data clarification, consistency/logic checks and querying
7. Medical Coding – MedDRA, WHO – ART, COSTART, WHODRUG
8. Data Validation and Query Management
Comptek Pros Inc provides a broad range of Validation services in support of clients’ process, manufacturing, laboratory, and enterprise systems.We bring a full understanding of pharmaceutical, biotechnology, and medical device business processes to a practical risk-based approach for validation
Computer systems validation
Comptek Pros Inc provides a broad range of Computer System Validation (CSV) services, by verifying the controlled development and implementation of computer systems, we can help clients ensure the integrity, reliability, and availability of their regulated business data to support the production of quality products and protect patient safety.
1. System Requirements and design review
2. System development and verification (Installation qualification/ operational qualification/ performance qualification)
3. System operation (Data archiving/ Disaster recovery/ Back-up and Recovery)
4. Sytem Retirement (Data Migration strategies and verification)
Process validation Through process validation, Comptek Pros Inc establishes documented evidence for our pharmaceutical, biotech, API and medical device clients to ensure process and product monitoring via consistently producing a product that meets its predetermined specifications and quality attributes. This process validation goes for all aspects of manufacturing, filling, sterilizing and packaging.
We possess the knowledge of the critical processing steps, quality attributes and sampling strategies, which allows our Process Validation engineers to challenge the robustness of the process during the development and execution of the process validation studies.
Product Performance Qualification- our goal is to help our clients every step of the way. That includes through product performance qualification. According to the FDA, the purpose of product performance qualification is: “to demonstrate that the process has not adversely affected the finished product and that the product consistently meets its predetermined specifications and quality attributes.”
We offer consultancy in the following services:
1. FDA Process Validation
2. Process Performance Qualification (PPQ)
3. Guidance for Industry Process Validation General Principles & Practices
4. Process Validation Guidelines
5. GMP Process Validation
Computer systems validation
Comptek Pros Inc provides a broad range of Computer System Validation (CSV) services, by verifying the controlled development and implementation of computer systems, we can help clients ensure the integrity, reliability, and availability of their regulated business data to support the production of quality products and protect patient safety.
1. System Requirements and design review
2. System development and verification (Installation qualification/ operational qualification/ performance qualification)
3. System operation (Data archiving/ Disaster recovery/ Back-up and Recovery)
4. Sytem Retirement (Data Migration strategies and verification)
Process validation Through process validation, Comptek Pros Inc establishes documented evidence for our pharmaceutical, biotech, API and medical device clients to ensure process and product monitoring via consistently producing a product that meets its predetermined specifications and quality attributes. This process validation goes for all aspects of manufacturing, filling, sterilizing and packaging.
We possess the knowledge of the critical processing steps, quality attributes and sampling strategies, which allows our Process Validation engineers to challenge the robustness of the process during the development and execution of the process validation studies.
Product Performance Qualification- our goal is to help our clients every step of the way. That includes through product performance qualification. According to the FDA, the purpose of product performance qualification is: “to demonstrate that the process has not adversely affected the finished product and that the product consistently meets its predetermined specifications and quality attributes.”
We offer consultancy in the following services:
1. FDA Process Validation
2. Process Performance Qualification (PPQ)
3. Guidance for Industry Process Validation General Principles & Practices
4. Process Validation Guidelines
5. GMP Process Validation
Our statistical services are composed of experienced Ph.D. and M.S. level of Statisticians/ Biostatisticians, SAS Certified (Base and Advanced) Programmers. Our efficient, experienced and skilled staff is expert in the design and analysis of Phase I–IV clinical trials with varying deOur statistical services are composed of experienced Ph.D. and M.S. level of Statisticians/ Biostatisticians, SAS Certified (Base and Advanced) Programmers. Our efficient, experienced and skilled staff is expert in the design and analysis of Phase I–IV clinical trials with varying designs, such as parallel group, cross-over, Bayesian designs, pharmacokinetic/ pharmacodynamic evaluations, therapeutic equivalence testing, and sequential designs.
Our statistical services include:
1. Study design and analysis planning
2. Statistical Analysis Plan (SAP)
3. Central randomization (paper or electronic)
4. Table & Listing validation and Quality Control
5. Complete final analyses (Phase I–IV)
6. Interim & meta-analyses
7. Ad-hoc and exploratory statistical analyses Statistical consultingsigns, such as parallel group, cross-over, Bayesian designs, pharmacokinetic/ pharmacodynamic evaluations, therapeutic equivalence testing, and sequential designs.
Our statistical services include:
1. Study design and analysis planning
2. Statistical Analysis Plan (SAP)
3. Central randomization (paper or electronic)
4. Table & Listing validation and Quality Control
5. Complete final analyses (Phase I–IV)
6. Interim & meta-analyses
7. Ad-hoc and exploratory statistical analyses Statistical consultingsigns, such as parallel group, cross-over, Bayesian designs, pharmacokinetic/ pharmacodynamic evaluations, therapeutic equivalence testing, and sequential designs.
Our skilled teams of billing and coding experts have in-depth knowledge and hands-on experience on working with Medicare, HIPAA and Medicaid regulations. Our team has a thorough understanding of procedural and diagnostic coding, accounts payable management and electOur skilled teams of billing and coding experts have in-depth knowledge and hands-on experience on working with Medicare, HIPAA and Medicaid regulations. Our team has a thorough understanding of procedural and diagnostic coding, accounts payable management and electronic medical claims submission.
Our skilled medical billing and coding experts are proficient with:
ICD-9, ICD-10, CPT and HCPCS codes across different specialties
Payer-specific medical coding requirements
Governmental, regulatory and insurance requirements
Our certified medical coders (CPC) keep themselves updated with constantly-changing trends in the medical industry, especially in ICD-9, CPT and HCPCS codes.
We also stay current with the latest versions of medical coding software such as Encoder Pro and Flash Code.
Staffing & Outsourcing Solutions:
Comptek Pros Inc is renowned for quality staffing and outsourcing services. Our customized staffing solutions match the personnel requirements of the clients. Your requirement for personnel may be on project basis or on turnkey basis, we are here to offer quality people and value-driven outsourcing processes for your business.
Our skilled medical billing and coding experts are proficient with:
ICD-9, ICD-10, CPT and HCPCS codes across different specialties
Payer-specific medical coding requirements
Governmental, regulatory and insurance requirements
Our certified medical coders (CPC) keep themselves updated with constantly-changing trends in the medical industry, especially in ICD-9, CPT and HCPCS codes.
We also stay current with the latest versions of medical coding software such as Encoder Pro and Flash Code.
Staffing & Outsourcing Solutions:
Comptek Pros Inc is renowned for quality staffing and outsourcing services. Our customized staffing solutions match the personnel requirements of the clients. Your requirement for personnel may be on project basis or on turnkey basis, we are here to offer quality people and value-driven outsourcing processes for your business.