Customized Training and Consultations

At FDAMap, we help accomplish regulatory and compliance objectives of pharma/medical devices/clinical trials companies with our customized training programs and one-on-one consultation with regulatory and compliance experts. Our consultants and trainers have decades of experience in handling complexities in drug and device development, clinical trials, FDA regulatory procedures and compliance, and post approval manufacturing and marketing.

Areas Covered:

• Product Development Strategy: Gap analysis, IND/IDE strategy, product development plans, investment portfolio analysis.

• US FDA Compliance: Meetings with FDA, regulatory strategy development, clinical trial planning/development/management, clinical trial or market approval applications (IND/IDE/NDA/BLA/PMA), electronic submissions, FDA premarket approval.  
• Quality Assurance and Quality Control: Preparation for Audits by FDA and other regulators (GMP/GCP/GLP), validation review (process, software and method), responding to audit findings (e.g., FDA 483, Inspection Report Response), Testing requirements.
  

• US Authorized Agent Services:  Representing to US FDA for license, registration, import-export, and regulatory filings.
  
• European Medicines Agency (EMA) Compliance – IMPD, MAA, Meetings, Audits, and strategy development and execution.
  
• Pharmacovigilance: Post-market surveillance, Patient support (Toll-free, online and email support and reporting), REMS, Registry studies, Annual Reports.
• Recruitment for Clinical Trials: Recruitment strategies, advertisement campaigns, social media campaigns, patient support (Toll-free, online and email screening).

Benefits:

• Cost-effective: By getting instructors to your facility, transportation and hotel costs for attendees can be avoided. The per trainee cost can be further reduced by our fixed price bulk certification options.
• Convenience: Courses can be scheduled at the location of your choice in order to accommodate schedules and maximize resources.
• Expert Instructors: We have top rated instructors who are renowned in their industry having an enriching experience. You get to choose your instructor from a list provided. Resumes and pre-training interviews with our instructors are available, upon request. 
• Flexibility of training platform: The training can be conducted in-person at your facility or at another location of your choice. You can also avail it through the web (virtual training), recorded tapes for attendees who miss a portion of the training for self-training at their pace, and any other format preferred.
• Accredited Content: FDAMap provides certifications for completion or training and accreditation for training by top experts based on quizzes, questionnaire, exams, as needed. Accreditation and certificates can be used in personnel training records and other purposes. 

FDAMap can create training customized to fit your needs at your facility or another location preferred by you. On-Site training is a very cost-effective way to train a group of employees than the other training alternatives. FDAMap handles all aspects of the in-site training such as developing a course that fits your training requirements, selection of a suitable instructor, logistics of organizing your training, and registration and certification of the trainees. 

We also take care of any special requirements you may have for a given training such as travel of off-site participants, meals during training, networking receptions, and confidentiality agreements. Our experts are also available for one-on-one consultation to trouble-shoot your regulatory, clinical trials and compliance issues. Our experts are available for ad hoc consultations on an hourly basis or task-based consultations based on expected deliverables. 
 
All of our training and consultation offerings can be customized to your company's specific processes, and can be held in-person or on the web (virtual seminars). If you cannot find what you need in our current library of training, we can design, develop and deliver original courses to address your organization's unique compliance training needs.

We keep things simple and straight-forward, give equal attention to praise and criticism both, so that we continue doing the things meticulously we do well and improve where required. We aim to build better platforms for interactions for experts and novices, alike, enabling them to come together to learn, contribute, and make a difference.

For more information on the training, content, instructors, and cost estimates, please contact Shai Deb or Peter Brown at 410-501-5777 or write to pbrown@fdamap.com or shaideb@fdamap.com.