Pen and Paper
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Welcome to Pen & Paper

The Team

Health Regulations are constantly changing to make the world a better place. We are a team of experienced professionals who have inside information and insight about all types of regulations. Our professionals are also constantly upgrading themselves to raise the standards of Medical Devise Consulting Regulatory

  • Give regulatory help and support.
  • Advice and rectify critical matters.
  • Plan strategies to overcome common problems.
  • Assist you to understand and get to know existing and new policies.

We Strive To Make The World A Healthier Place

Credentials

Certification body has accepted the clinical evaluation without any query or question. Thank you. - Uetake Shigeru

I am very impressed by your work. Thank you so much! - Martina Sander

You are a great help. THANKS for your friendly way and your VERY hard work on this dossier. - Bernd Kuttler

Kirtida has nicely resumed the animal literature for PTFE coated device. - Dr. Malte Neuss

The Company

Pen and paper are the answer to your regulatory clearance, regulatory compliance requirements, preparation for submission, conformity to requirements and sales improvement. We have been in this business for so long that we can tell you which side the wind will blow next.

Contact Details

Owner & Technical Head
Kirtida Rana
Click here to get contact details

Services

Our Services

Services

We will walk with you every step of the way to ensure the success and marketability of your healthcare product. We work with any and every medical product. We can address any process and need.

  • Site selection, Plant set up, Quality Management System Implementation as per CDSCO (DCGI)
  • Documentation and follow ups at Gujarat FDCA and DCGI for Test Lic, Mfg Lic and Import Lic
  • Training and guidance for the state FDCA and DCGI Audit
  • ISO 13485 quality system implementation, document preparation and audits
  • ISO 13485 training for medical device companies
  • Technical file preparation for all classes of devices for CE Marking
  • Gap analysis of prepared technical file and design dossiers
  • Clinical Evaluation Report preparation
  • Design Master File preparation
  • EUAR /EC Representation services
  • US FDA Approval – registration, listing and representation
  • 510k Application preparation and Gap Analysis
  • ANVISA Approval, Audit, Gap Analysis
  • Show you how to adhere to the regulations,
  • Guide you through new regulatory specifications,
  • Support you through the submission,
  • Guarantee certification and approval for your products,
  • And even take care of your internal and external auditing compliances.
  • We also entertain pharmaceuticals & cosmetics enquiries.

In short, we do all we can to ensure approval and success for your remarkable product.

Ensuring Success

Whether you need to increase your sales or introduce a new medical device or equipment medicine in the market, we can help.
We also open the door to

  • Global certification for quality to capture new markets,
  • And winning strategies.

Our Strategy

Our Strategy

Our work is to make your product into the highest quality available in the market which at the same time, conforms to the regulations laid down by the governing Regulatory Agencies. Pen and Paper has extended its services to cover the regulations of local and international regulatory bodies. With our assistance you can register for any market.

Our Leverage

We will give 100% support to enable your product to meet all the regulatory and data prerequisites and take the best submission method. This is made possible by our business solution which is customized according to your needs and products. We take into account the entire life-cycle of the product and so we also do

  • Planning to eliminate risks
  • Arrange meetings with agencies
  • Address queries raised by them
  • pre-planning and preparation before meetings.
  • Support throughout the entire marketing life

Customer Satisfaction

Customer Satisfaction

We always strive to satisfy our customers who trust our judgment and work ethics. Our clients like our strict devotion to work schedules. Moreover our knowledge helps them to avoid unnecessary corrections and avoidable delays. This, perhaps, explains why more and more people prefer us and our services for their company.

Regulatory clearance is all in a day’s work for us. We are leaders and innovators of regulatory strategy and regulatory conformity. We are your seal of achievement for regulatory accomplishment.

  • EU approval of class III cardiovascular implant (Indian client)
  • Indian approval of class III cardiovascular implant (Indian client)
  • Indian approval of class III orthopedic implant (Indian client)
  • Change notification after a merger (EU client)
  • Gap analysis of an IVD device dossier (EU client)
  • USA approval of an IVD device (Turkish client)
  • USA approval of electromedical device (Indian client)
  • EU approval of emergency evacuation apparatus (USA client)
  • EU approval of wound care product (Indian client)
  • Mexican approval of a combination product (CIS client)
  • Brazilian approval of a cardiac device (Indian client)
  • EU approval of syringes (Turkish client)
  • USFDA approval of a wound care product (far east client)
  • Gap analysis of syringes dossier (Chinese client)