Global Allied Pharmaceuticals

A complete suite of medical writing functions supporting clinical trial documentation from early stages through post-marketing and mature product development, including regulatory writing, safety writing, and narrative writing.

Textbook focusing on global pharmacovigilance and epidemiology.

Self-help and companion books focused on allied health, biopharmaceutical development, immune oncology, cancer treatment, global pharmacovigilance, clinical development, and medical affairs.

Expertise provided by clinical/industry trained specialists in Medical Oncology, Surgical Oncology, and hematology for the development process, clinical challenging data review, safety signals, and ad hoc responses.

A novel modality that provides enhanced solubility of chemotherapeutic agents and class III-IV compounds.

Comprehensive clinical development and trial management services spanning Phase I-IV studies, biostatistics, monitoring, data management, regulatory support, and safety/surveillance.

Planning will be executed at all stages with customized services as per client’s request, dealing in drug discovery, pre-clinical testing, clinical trials and post market drug safety and life cycle management.

Full or bespoke services for signal detection adhering to European and U.S. compliance guidelines to review and generate potential adverse event signals.

A turn-key and strategic consulting services company serving the pharma, biotech, and medical devices industries.

GAP provides extensive experience in designing and conducting oncology studies through its strategic consulting team services, which include optimization tool box planning validation.

Bespoke or full services for drug safety case management, following a four-step process including case intake, processing, assessment, and distribution.

Expert drug safety physician team with over a decade of experience providing safety data analysis, clinical development program management, therapeutic evaluation, single case processing, and aggregate report preparation.

Global medical monitoring services encompassing safety management, protocol design, study level data review, trip report trend analysis, medical expertise during key activities, and regulatory interaction.

Global Allied Pharmaceuticals offers Safety Assessment Committees (SAC) services to assist biopharmaceutical and medical device companies with assuring compliance, safety data monitoring, and reporting throughout a drug's development program and beyond.

Literature search services provided by Global Allied Pharmaceuticals, including gathering information related to medicine and public health for patient benefit and research purposes, database searches, search strategies development, and auto alerts.

Professional services from Global Allied Pharmaceuticals to assist sponsors in officially obtaining exemptions from the FDA through Investigator IND, Emergency use IND, and Treatment IND submissions.

A novel modality and bioavailability boosting technology that provides enhanced solubility of chemotherapeutic agents, better penetration into cancerous tissues, and helps overcome natural physiologic barriers such as the Blood Brain Barrier.

GAP offers a qualified team of aggregate safety physicians to prepare global regulatory aggregate reports on a continuous basis per regulatory guidelines, including PSUR, PADER, PBRER, ASR, and DSUR.

Comprehensive consulting and management services covering clinical study and trial operations from early cost-effective planning to product delivery, regulatory approval, and results submission for market authorization.

Comprehensive audit readiness and inspection services providing a complete understanding of regulatory updates from the FDA and other agencies, delivering a prioritized list of actions to update clinical procedures.

Comprehensive support for drug sponsors to formally propose drugs for sale and marketing in the U.S.A. upon meeting FDA safety and effectiveness standards.

Risk management program initiation with classification and evaluation of risks related to pharmaceutical products.

Specialized regulatory consulting and submission services for biological products permitted under the Public Health Service (PHS) Act.

Source data verification (SDV) service checking for accuracy and consistency of data transcribed from source documents, utilizing experienced CRAs and strategies such as retrospective and online monitoring.

US-based IT outsourcing services helping small and medium enterprises in North America and Europe with cost savings and distribution turnaround time.