Professional Pharmaceutical Services, Offered Online

Recommend solutions for communicating with the FDA review divisions

Provide assistance to a variety of dosage forms such as Gels, Liquid-filled capsules, Radiopharmaceuticals, smaller peptides, creams, and vaginal rings

Provide expert advice for the development of complex generic dosage form such as Liposomes, small molecule peptides, evaluate Q1/Q2 sameness, and advice for filing control correspondence related matters to the Agency.

Strategy Consulting

From Product Development to Technical Strategy for FDA submission, and regulatory support, the firm can handle a broad range of activities.

  • Liposomes/Injectables
  • Gels
  • Liquid-Filled Capsules
  • Radiopharmaceuticals
  • Smaller Peptides
  • Creams/Topicals
  • Vaginal Rings & More

The company provides expert advice for developing complex generic dosage, evaluating Q1/Q2 sameness, and filing control correspondence related to the agency's hands-on experience with HPLC, GC, IR, DSC-TGA instrumentation, Polymorphism, and Particle size distribution measurements.

Pharma Modus LLC

Technical Advisory

Having started after departing CDER as an FDA-level stability expert, this company advises firms on their assessment of stability data. This includes determining expiration dating, filing supplements to increase or maintain expiration dating, and stability protocols.

The company also assists firms in evaluating their Type II and IV DMF submissions prior to reaching CDER-FDA Audit ANDAs for completeness.

Additional Services

  • Formulate control correspondence questions to the Agency to develop new and generic drug products.
  • Assist firms to evaluate their new Type II, IV DMF submissions prior to reaching CDER-FDA.
  • Audit ANDAs for completeness assessment and technical evaluations prior to submission to OGD where drug and a device are involved.
  • Evaluate approved NDAs, ANDAs, INDs for future purchase by potential investors/PE firms for further investment decisions, and advice on any technical or supply chain issues.