Providing contract and consultancy support to the Pharmaceutical and Medical Device Industries

BECKAL’s contract and consultancy support services include:

• Regulatory Strategy Pharmaceutical

• Drug Delivery

• Combination Products

• Nasal Spray Products

• Clinical Trial Applications (CTAs)

• Investigational New Drug (INDs)

• Clinical Trial Operations

• Good Clinical Practice (GCP) compliance

• Product Development Activities

• Chemistry Manufacturing Controls (CMC)

• Verification and Validation activities

• Current Good Manufacturing Practice Compliance (cGMP)

• FDA inspection readiness

• New Drug Applications (NDAs)

• Marketing Authorisation Applications (MAAs)

• Post Approval Support

• Scientific Meetings 

• Quality Management Systems ISO 13485

• Regulatory Strategy Medical Device

• Interactions with Regulatory Authorities

• Interactions with Competent Authorities

• Technical file review 

• Design Dossier review

• Technical Gap Analysis

• Quality System Gap Analysis

• Risk Analysis