C&A Regulatory Affairs specialists provide valuable aid in assisting clients to prepare the regulatory filing and submissions and ensure inspection readiness of the manufacturing site. We are qualified to interfere with various levels of the projects and interface with the regulators as we navigate through any regulatory hurdles in a timely and efficient manner.

Our Quality Assurance experts can help you build or re-engineer your Quality Management System to comply with various regulatory requirements, while maintaining operation excellence and maximizing efficiency.   We review, write and develop Quality Manuals to include any supporting documentation, Quality Policies, Standards and Procedures, with a “Quality by Design” approach, to strengthen the foundations of your company’s operations.

C&A professionals will help you in your internal audits, assist in executing your validation plan, review your SOPs, or provide technical writing and investigation expertise for your deviations and complaints.    We prepare Annual Product Reviews including summaries, detailed data tabulation and statistical analysis.  We perform assessments and site evaluations on your behalf and our certified auditors have significant expertise conducting audits at suppliers of raw materials, active pharmaceutical ingredients and contract manufacturers for both sterile and non-sterile dosage forms. We also have expertise in auditing and qualifying medical device manufacturers, analytical service providers and microbiology laboratories.