Synterex

Synterex is listed as a small business research supplier in the Scientist.com network, with 1 site in 1 country.

Search companies, drugs, suppliers and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.

Sites 1

Countries 1

Type of company: Small business

Clinical Consulting

Clinical Study Reporting (CSR) Report results of clinical trials to regulatory agencies. This includes participant flow, baseline characteristics, outcome measures, statistical analyses, and adverse events.
Regulatory Compliance & Documentation Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.
Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.

Clinical Trials

Clinical Research Services Determine the safety and effectiveness of medications and medical devices.
Regulatory Affairs Consulting Receive assistance ensuring compliance with regulatory requirements.
Regulatory Operations Ensure that all specific regulatory documents are published and properly organized before submission.

Medical Communications

Abstracts Request services related to the writing and review of abstracts
Investigational Medicinal Product Dossier (IMPD) and Investigational New Drug (IND) Dossier Develop and submit Investigational Medicinal Product Dossier (IMPD) and Investigational New Drug (IND) Dossier
Medical Writing and Editing/Manuscript Development Communicate scientific, technical and health-related information to a range of audiences.
Patient Narratives Compliant collection and use of individual patient stories to illustrate the impact of a disease or treatment, often for training or empathy-building purposes.
Protocol and Study Reports Write protocol and study reports, specifically relating to the drafting, writing, and editing of Clinical Safety Reports.
Publication Writing Create further publication documents. Investigational device exemptions (IDEs) BLAs, MAA, PMA, eCTDs, informed consents, CMC and manufacturing reports, orphan drug designations (ODD), briefing books.

Show all 7 in Medical Communications 1 more

Regulatory Submissions and Compliance Draft, format, and submit documents to Pharmaceutical approval agencies according to documentation and guidelines. This includes documents such as NDAs, INDs, SUSARs, AE reporting, RMPs, and PSURS.

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Pharmacovigilance

Adverse Event (AE) and Serious Adverse Event (SAE) Reporting Report unfavourable and unintended events (e.g.: abnormal laboratory results, symptoms or disease associated with treatments) to regulatory bodies via the FDA's Adverse Event Reporting System (FAERS) or other...
Aggregate Safety Data Review Cumulative summary of safety information regarding the collection, analysis, and submission of aggregated safety data to health authorities at specified intervals.
Pharmacovigilance Literature Surveillance Conduct systematic and ongoing review of scientific and medical literature to identify new information about the safety profile of a drug. This process is crucial for detecting adverse drug reactions (ADRs) that may...
Regional Regulatory Consulting Regional regulatory consulting provides expert guidance on local regulatory requirements and processes to help companies navigate and comply with the specific rules and standards of different geographical regions...
Risk Management Plans (RMPs) Develop Risk Management plans (RMPs) that include information on a medicine's safety profile and plans for further pharmacovigilance activities designed to gain greater knowledge. These documents also explain how...
Safety Advisory Committees Collaborate with global experts to support safety surveillance monitoring and provide guidance on the safety of medicines and vaccines.

Regulatory Affairs

Medical Labeling Design and create medical labels that accurately reflect purpose, precautions and other information.
Regulatory Submission Documents Request services related to the submission and writing of New Drug Applications (NDA), Investigational New Drugs (INDs), and Investigator Brochures (IB) to the FDA and other regulatory bodies.
Risk Evaluation & Mitigation Strategy (REMS) Evidence required by FDA to support the benefit of treatment outweighs the risks. Purpose of REMS is to prevent, monitor, and manage serious risk by informing, educating, and reinforcing actions to reduce frequency...

Scientific Data Services

Cloud Computing Request on-demand computer resources specifically relating to large data storage and computing power.

Target Animal and Human Food Safety

Target Animal Safety (TAS) Studies Evaluate potential harmful effects associated with the use of a new animal drug in a controlled setting.

Other services

IND Writing Receive assistance with materials for an IND application.

Website: synterex.com

United States Dedham 1 site

Woman-owned Minority-owned

US small-business federal-contractor designation, self-certified in the U.S. federal System for Award Management (SAM.gov). Coverage is limited to matched U.S. small-business suppliers, so an absent designation is not evidence of its absence.

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