Our Services:

Costarica pharmaceuticals support all regulatory documentation DUNS registration, maintenance, Establishing web trader account, Drug establishment registration, Obtaining FEI number Obtaining Labeler code, Submitting NDC number, Self identification of facilities, Generating cover sheet for fee payment, Generating cover sheet for fee payment, Food facility registration, Blanket no change notification updating address changes if any

Costarica pharmaceuticals support submitting DMF to US FDA, EU countries, Health Canada, TGA and other regulatory bodies, Submitting VMF to USFDA using eSubmitter tool, Responding to the queries received from the agencies in a timely manner, Submitting CEP to EDQM, Responding to the queries received from EDQM and getting CEP approval in timely manner

Costarica pharmaceuticals also involved Evaluation of process for any possible geotaxis impurities and setting limits for the same as per the applicable guidelines, Setting specification limit for impurities, Providing guidance throughout life cycle of the product, Guiding on all regulatory issues faced during day to day activities (from customer or agency).

We also provide Training:

We specialize in offering training on different concepts of Pharmaceutical related programs like Quality Control, Quality Assurance, GMP, Regulatory, Validation, etc across Globally and Nationally. Our Core Team of Trainers is expertise in offering Industrial-level Training to the organization’s staff and core members.
We are committed to helping clients achieve long-term success and effectiveness in compliance, regulatory, and regulatory matters. We offer a complete set of training programs for all levels of the organization, from senior Managers to Bench Chemists and production operators. Our Training Program is customized to meet each organization’s requirements.

These are some of the training programs we offer:

• Quality Control
• Quality Assurance
• GMP
• Regulatory
• Validation

Explore our Services which offer a unique solution to many Pharma organizations. Our services include GAP Analysis, Audits, Validation, Risk Management, Regulatory Support, Vendor Qualification, Registration, and Training.
We provide consistent, cost-effective, and high quality consulting in the areas of regulatory, clinical, safety and manufacturing.