We Provide:

• New drug and generic drug’s (ANDA, NDA, DMF, MAA, ASMF, CEP, IND, CTA, etc) and Medical Device (510k & PMA) preparation, submission and life-cycle management, responses to deficiency letters;
• GMP audits, site preparation, and personnel training for API and finished dosage form (FDF) manufacturing sites
• Meetings with FDA and other Health Authorities
• eCTD compilation, validation and submission
• US/North America Agent for international pharmaceutical companies
• Label designs and SPL creations
• Regulatory affairs and patent consulting;
• Assistance in finding the best distribution channels / partners
• Pharmacovigilance