Pharma / Biotech

Pharma and biotech services encompass a wide range of activities and expertise aimed at supporting the pharmaceutical and biotechnology industries in various aspects of drug development, manufacturing, testing, and commercialization. Some of the services provided by the pharmaceutical and biotechnology industries include:

Contract Research Organizations (CROs): CROs provide outsourced research services to pharmaceutical, biotechnology, and medical device companies. These services may include preclinical research, clinical trial management, regulatory affairs, and data management.

Contract Manufacturing Organizations (CMOs): CMOs offer manufacturing services to pharmaceutical and biotechnology companies, including the production of active pharmaceutical ingredients (APIs), drug substances, drug products, and packaging.

Analytical and Testing Services: These services involve analytical testing of pharmaceutical products, raw materials, and formulations to ensure quality, safety, and compliance with regulatory standards. This includes method development, validation, stability testing, and microbiological testing.

Regulatory Affairs Consulting: Regulatory affairs consultants assist companies in navigating complex regulatory requirements and submissions for drug approvals, including interactions with regulatory agencies such as the FDA (Food and Drug Administration) in the United States and the EMA (European Medicines Agency) in Europe.

Clinical Trial Services: Companies offer various services related to clinical trials, including site management, patient recruitment, clinical data management, monitoring, and pharmacovigilance.

Drug Development Services: These services support the drug development process from discovery to commercialization, including medicinal chemistry, formulation development, pharmacokinetics/pharmacodynamics (PK/PD) studies, and toxicology.

Bioprocessing and Biomanufacturing: Bioprocessing companies specialize in the production of biopharmaceuticals such as monoclonal antibodies, vaccines, and recombinant proteins using biotechnological processes. Services include cell line development, fermentation, purification, and downstream processing.

Quality Assurance and Compliance: Consultants and service providers offer expertise in quality assurance (QA) systems, compliance audits, GMP (Good Manufacturing Practice) compliance, quality control (QC) testing, and regulatory inspections.

Supply Chain and Logistics: Companies provide services related to the procurement, storage, distribution, and logistics of pharmaceutical products, including cold chain management for temperature-sensitive drugs.

Medical Writing and Documentation: Medical writers assist in the preparation of various regulatory documents, clinical trial protocols, investigator brochures, scientific publications, and marketing materials.

Our services are offered within the pharmaceutical and biotech industries, and the sector continues to evolve with advances in technology, regulatory changes, and market demands.