It is imperative to have proper Chemistry and Manufacturing Controls (CMC) not only for compliance with regulations but for patient safety as well. It is our priority at LingvaText to have a comprehensive understanding of CMC requirements and being able to deliver accurate translations by qualified medical translators and editors with backgrounds in Pharmacology, Pharmacogenomics, Biotechnology, Biochemisty, Cell Biology, Virology, Molecular Biology, Genetics, etc.

We provide best quality translation of the following, starting with the development phase through the post-approval phase:

• IND, NDA, BLA, ANDA
• Regulatory Dossiers
• Quality Agreement and SOP
• Quality Control documents
• GMP Pre-approval
• Process Validation Protocols
• DMF Writing
• Manufacturing changes, comparability protocols, etc.

LingvaText ensures high-quality translations needs for your company to streamline the entire process from preclinical studies to post-marketing approval research, ultimately yielding a more efficient and positive result in the following:

• Nonclinical Strategy/Program
• GLP Toxicology Studies
• GLP PK Studies
• Non-GLP Pharmacodynamics Studies
• Protocol and Report Review for PK/PD/Toxicology
• Study Report Composition, Review & Results Interpretation

Clinical Consulting Services

The process of submitting NDAs and BLAs is complex. Our team of multi-language expert translators with various life science degrees and bilingual clinical professionals apply their professional understanding of regulators' intricate processes and criteria to help you to speed up the approval process with great translation.

We translate all kinds of Clinical documents, including the following:

• Clinical Study, Synopsis, Protocol
• GCP Inspection
• GMP Pre-Approval Inspections
• Pharmacovigilance
• Annual Report
• ICF and IB Translation
• Orphan Drug Designations (ODDs)
• Pediatric Study Plans (PSPs)

LingvaText's language team is comprised of professionals with background in the pharmaceutical and biotechnology industries. The precise and savvy translation they provide is always designed to help you gain approval quickly and proceed seamlessly into the manufacturing phase as soon as approval is granted – so your product can reach the market and patients as soon as possible.

LingvaText is your one-stop-shop for all your CMC, Non-clinical and Clinical translation needs, but our language support extends beyond approval.

You gain access to one powerful team comprised of top language specialists in each area of the healthcare industry, who can work together to ensure high quality translation and compliance throughout the manufacturing process and commercialization in the US.

Whether you need translation services related to GMP inspections, Quality Control, or anything else, our team will put our extensive experience to work and provide you with translations that are tailored to the regulators' requirements.