+91 400 83 85

Expertise & knowledge

Established in 1991


Services

RCAPharma, S.L. was founded in 1991 to offer expert support in regulatory affairs, pharmacovigilance and market access/P&R to pharmaceutical companies to introduce their products in the Spanish market

Carmen García

REGULATORY AFFAIRS

RCAPharma expertise and wide-ranging experience in regulatory affairs, is at your service, as well as qualificaction and educational background of our personnel

Contact us
  • Preparation of dossiers for Marketing Authorization Applications (CTD format).
  • Transformation of dossiers to e-CTD.
  • Definition of Regulatory Strategy.
  • Preparation of Expert Reports/Clinical and Non-Clinical Overviews.
  • Submission and management through to approval of applications via EU. Mutual Recognition and national procedures.
  • Follow-up of applications including answering of authorities' concerns , Contact us with authorities involved and filing of appeals.
  • Life Cycle Management for products marketed in Spain (variations and renewals).
  • Legal and Regulatory assistance in setting up new companies in Spain.
  • Regulatory due diligences.
  • PIL Readability Tests.
  • Product Information Updates and Translation (SPC, Patient Leaflets, Labelling text).
  • Review/approval of packaging materials for submission and printing.
  • Compliance with advertising and promotional laws. Submission to the authorities.
  • Decentralised (DCP) and Mutual Recognition (MRP) procedures.
  • Steps in the Spanish Agency for importation of controlled substances or commercialization of blood-derivative products.
  • Dealing with official regulatory data bases in behalf of MAH.

  • Quality Affairs

  • Distribution facilities, warehousing. GDPs compliance.
  • Medical Device companies.
  • Qualified Person services.
  • Audit services.