Documentation
Our clients turn- and return to us for inerrant technical documentation. You can trust us to make the ‘right’ recommendations for your current documentation system of product and process. We are adept at identifying documentation weaknesses and have become reliable consultants for quality control and quality assurance systems. Complete, consistent and accurate data is our documentation philosophy.
Documentation Services
We provide a comprehensive range of documentation services including:
- Scientific proofreading
- Validation Life Cycle (URS/FRS/RA/DS/DQ/IQ/OQ/PQ/CLV/CC etc.)
- Product Dossiers
- Technical Writing
- Standard Operating Procedures
- Policies
- Validation Master Plans
- Quality / Biosafety Manuals
Regulatory Submissions
We assess and streamline regulatory submissions and recommend the best way forward for your plans. We can also help you draft the Common Technical Document (CTD). Our experts will polish and review your regulatory submissions in terms of content and presentation. We advise and analyse regulatory requirements and package your data for hassle-free submissions.
Technology Transfer
Whether you’re moving from one manufacturing site to another, or from one process train to another, we can generate precise Technology Transfer (TT). We consult on technology transfer documentation depending on facility and equipment capabilities. All TT protocols and reports are expertly reviewed to support and sustain a seamless transition.