Welcome PharmaMediQ Consultancy

PharmaMediQ is your trusted consulting company in Germany, specializing in medical and pharmaceutical solutions. We offer tailor-made consulting for your company.

Service

Regulatory Affairs

Medical device and medicine approval consulting: regulatory support and approval procedures.

Wholesale License and warehouse inspection.

 

GxP Audit and Pharmacovigilance

GxP Audit Suggestion and SOP plan.

Pharmacovigilance advice: monitoring and evaluation of safety aspects.

 

Product and Market Strategies

Market access and importation strategies.

Product Development and appropriate suppliers.

 

Frequently Asked Questions

What are the advantages of consulting with PharmaMediQ?

Our advice guarantees tailor-made solutions and in-depth expertise.

How does the medical device and medicine regulatory process works in different countries?

Answer: The regulatory requirements vary by region. In the U.S., drugs must go through the FDA’s approval process, which includes preclinical testing, clinical trials (Phase I, II, III), and submission of a New Drug Application (NDA) or Biologics License Application (BLA). In the EU, the process is managed by the EMA. Regulatory hurdles typically include proving the safety, efficacy, and quality of the product.

How do we maintain data integrity in compliance with regulatory requirements?

Answer: Data integrity is crucial in all GxP areas (GMP, GLP, GCP). Consultants recommend adopting the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete) for data management. This includes validating computerized systems, ensuring audit trails, and implementing strict document control processes.

How to manage authority audits?

Managing audits, especially in highly regulated industries like pharmaceuticals, requires thorough preparation, effective communication, and a systematic approach. Whether the audit is internal or external (e.g., by regulatory authorities like the FDA, EMA, or MHRA), the goal is to demonstrate compliance with applicable standards (GxP, ISO, etc.) while identifying areas for improvement.

Contact us

Contact us for individual advice on medical device and medicine about regulatory affairs, GxP Audit and Pharmacovigilance consulting, product and market strategies.

Standort

PharmaMediQ
Germany

 

About us

PharmaMediQ is an established consulting firm in Germany that specializes in the pharmaceutical industry. Our experienced team offers tailor-made solutions for your challenges.