Peggy J. Berry, MBA, RAC, is the Principal Consultant at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs, and project management topics. Synergy's team provides expert consulting services to help clients plan, execute, and manage their regulatory strategy and pharmaceutical development. Whether you need expert assistance drafting and reviewing submissions or evaluating audit readiness, Synergy's experts will deliver optimal support. Staff training is the most important internal factor relating to a company's efficiency and success. At Synergy, all of our instructors work in the pharmaceutical development and regulatory affairs industry, so they have faced the same obstacles that your staff members will and can provide the practical insight needed for regulatory success. -CONSULTING Regulatory Strategy Submission Preparation (IND, CTA, NDA, CTD, DMF, MAA, etc.) Audit Readiness (GMP, GCP) Promotional Materials Review Job Descriptions SOPs -TRAINING CTD/eCTD content and preparation Regulatory strategy development FDA meeting request, preparation, conduct & follow-up EU meeting requests, preparation, conduct & follow-up GCP audit preparation GMP audit preparation Annual GCP training Annual GMP training SOP development Clinical monitoring Clinical development (all phases) Drug development ANDA requirements Regulatory leadership & development Regulatory department management Risk assessment and mitigation Safety requirements Clinical project management Promotional materials compliance Global regulatory agency meetings Technical writing