Science Writing

Biopharmaceuticals & Pharmaceuticals

Our primary area of specialization for our writing services is biopharmaceuticals—proteins, monoclonal antibodies (mAbs), antibody–drug conjugates (ADCs), bispecific antibodies, gene and cell therapy, and all other types of large-molecule therapeutics and new therapeutic modalities—as well all aspects of small-molecule pharmaceuticals and vaccines.

Key topic areas relate to research and development, analytical chemistry, quality, data management, and digital transformation, such as:

• upstream processing

• downstream bioprocessing

• process development

• continuous processing

• scale-up

• analytical chemistry, analytical method development, and analytical techniques

• product characterization

• process analytical technology (PAT)

• quality control and quality assurance (QA/QC)

• process validation

• regulatory and pharmacopeial compliance with regulations and guidance from the US Food and Drug Administration (FDA), United States Pharmacopeia (USP), the European Pharmacopeia (EP), the Japanese Pharmacopeia (JP), the European Medicines Agency (EMA), the UK Medicines & Healthcare products Regulatory Agency (MHRA), the National Medical Products Administration of China (NMPA), and the International Council for Harmonisation (ICH)

• current good manufacturing practices (cGMPs)

• good laboratory practices (GLPs)

• laboratory automation

• data integrity

• digital tools for the laboratory, such as electronic laboratory notebooks (ELNs)

• digital transformation

• blending

• tableting.

Contact us to learn more about how we can meet your needs for professional technical and marketing writing.