We help you navigate the complexities of compliance every step of the way, from manufacturing to clinical study audits, from establishing basic SOPs processes to ensuring inspection-readiness.
Your needs are variable—sometimes you need a full-time resource, while other times you need flexible support. Whether you’re looking for on-demand short- or long-term support with individuals or teams, we can help.
We have depth of experience supporting clients to clarify goals, capabilities, timing, and gaps to present you with custom-crafted solutions. We leverage your internal team or outsourced providers and fill any gaps you may have.
Grow, streamline, or improve operations by a review of current processes and ensure fit-for-purpose SOPs and work instructions, systems, and controls are in place.
We can qualify and perform for-cause or routine surveillance audits for your suppliers and vendors.
During clinical development, our GXP experts can offer guidance and support to ensure your staff and suppliers are working in compliance with local, federal, and international regulations.
Our professionals are skilled at creating, updating, and maintaining quality systems (QS), and quality management systems (QMS) in addition to supporting risk management during clinical development and product commercialization.
Our professionals can identify and investigate issues affecting quality, safety, and compliance through the Corrective and Preventative Action (CAPA) process.
Throughout the manufacturing process, from the receipt of raw materials to the release of drug substances and drug/device products, our consultants can support the review, investigation, and approval of controlled documents.
Preparing for an agency inspection is a comprehensive process, and our teams are skilled at evaluating and ensuring documentation and processes are in place to illustrate compliance.
Meet with a member of our team to find the right solutions for your life sciences company.
Talk to UsIndustry Insights
By Jenny Thayer, BioBridges’ SVP Medical, Regulatory, Scientific Communications While a quality control (QC) review of a regulatory document is essential, it is often the easiest step to skip or squeeze when meeting a timeline. By understanding its benefits, you can become a QC review advocate. The Document Quality Control: Risks vs Benefits Risks of […]
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Working in life sciences is exciting because of the ever-changing landscape. In a constantly evolving industry, new regulations and legislation continuously emerge. As a life sciences professional, staying current is imperative for your career. Here are five critical regulatory changes that you need to understand: #1) Concurrent Submission and Review of Oncology Products As you […]
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As an established pharmaceutical company focused on neurological diseases was preparing for a submission and realized that they had not fully completed the necessary quality GMP and GCP activities during the course of the program.
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A virtual company submitted their first IND and needed an effective and nimble project team to oversee their clinical program, develop clinical documents for regulatory submissions, and support overall business development.
Industry Insights
A premier academic institution and research center with critical partnerships with large pharma, biotech, and device organizations recognized a gap: they required industry experience to effectively collaborate with their sponsor partners. Additionally, our client faced the emerging challenges of managing the ever-changing considerations resulting from COVID-19, which were amplified due to their lack of experience with a remote work force.
